Custom Pharmaceutical Packaging | FDA-Compliant Drug Cartons for OTC and Rx Products
FDA and state pharmacy board compliant pharmaceutical packaging for OTC and prescription drug products
Why Choose Us for Pharmaceuticals Packaging
Pharmaceuticals Packaging Products
Custom packaging solutions tailored for pharmaceuticals businesses
Pill Boxes
Custom pill boxes for pharmaceutical and OTC medication brands. Compliance-ready packaging with child-resistant closures and drug facts panels.
Medicine Boxes
Custom medicine boxes for prescription and OTC drugs. Professional pharmaceutical packaging with complete regulatory compliance.
Syringe Boxes
Custom syringe boxes for medical syringe packaging. Sterile-compatible, tamper-evident with precise syringe accommodation.
Inhaler Boxes
Custom inhaler boxes for respiratory medication devices. Device-specific packaging with usage instructions and compliance labeling.
Eye Drop Boxes
Custom eye drop boxes for ophthalmic medication brands. Small bottle packaging with sterile integrity and precise dosage information.
Bandage Boxes
Custom bandage boxes for adhesive bandages and wound care products. Retail-ready packaging with easy-access dispensing design.
Cream Tube Boxes
Custom cream tube boxes for topical medications. Tube-fit packaging with drug facts and usage instructions.
Vitamin Blister Boxes
Custom blister pack boxes for vitamins and supplements. Calendar-style packaging with daily dose organization.
Test Kit Boxes
Custom test kit boxes for home diagnostic and medical testing products. Multi-component organization with instruction integration.
Oral Care Boxes
Custom oral care boxes for toothpaste, mouthwash, and dental products. Tube and bottle packaging with dental brand design.
Nasal Spray Boxes
Custom nasal spray boxes for decongestant and allergy medications. Compact packaging with actuator protection and drug facts.
Medical Glove Boxes
Custom medical glove boxes for exam and surgical gloves. Dispensing design with size coding and latex-free identification.
Pharmaceutical Cartons
Custom pharmaceutical cartons for drug packaging. Serialized, tamper-evident folding cartons with complete regulatory compliance.
Cough Syrup Boxes
Custom cough syrup boxes for liquid OTC medication brands. Bottle-fit packaging with drug facts, dosing cup accommodation, and child-resistant design.
About Pharmaceuticals Packaging
Pharmaceutical packaging operates under the most stringent regulatory framework of any consumer goods category -- FDA 21 CFR labeling regulations, state pharmacy board requirements, PPPA child-resistant packaging requirements, and serialization requirements under the Drug Supply Chain Security Act (DSCSA) all create a compliance landscape where packaging errors have regulatory consequences. Pharmaceutical packaging must be designed, specified, and produced with the same rigor as the drug product itself.
OTC Drug Labeling Requirements
Over-the-counter drug products require the Drug Facts panel in the format specified by FDA 21 CFR Part 201 -- a standardized panel presenting active ingredients, uses, warnings, directions, and inactive ingredients in a prescribed order and format. The Drug Facts panel format is mandatory and cannot be modified for design purposes. OTC drug carton packaging must also carry the required tamper-evident feature statement, the lot number and expiration date, and the principal display panel with product name, dosage form, and net quantity.
Serialization and Track-and-Trace
The Drug Supply Chain Security Act (DSCSA) requires that prescription drug products bear a product identifier -- a 2D datamatrix barcode encoding the National Drug Code, serial number, lot number, and expiration date -- on each individual saleable unit. This serialization requirement creates specific packaging print quality and placement requirements for the 2D datamatrix code. The code must be human-readable (lot number and expiration date in adjacent text) and machine-readable (2D barcode scannable by track-and-trace systems throughout the pharmaceutical supply chain).
Drug Facts Panel Compliance on OTC Packaging
The Drug Facts panel is a mandatory FDA-prescribed labeling element for all OTC drug products sold in the United States. FDA 21 CFR Part 201.66 specifies the exact format -- including the panel heading, the sequential presentation of active ingredients, uses, warnings, directions, other information, and inactive ingredients -- and the minimum type sizes for each element. The Drug Facts panel cannot be modified for aesthetic or space reasons; if the panel does not fit on the available label area, the label area must be enlarged or the product reconsidered for OTC drug status. Our pharmaceutical packaging dieline templates pre-position the Drug Facts panel with all required elements in FDA-compliant format.
DSCSA Serialization for Prescription Drug Packaging
The Drug Supply Chain Security Act requires prescription drug product serialization -- each individual saleable unit must bear a 2D datamatrix barcode encoding the National Drug Code, a unique serial number, the lot number, and the expiration date. The 2D datamatrix code must be printed at a minimum size and contrast that ensures scannability by track-and-trace systems at each point in the supply chain. Adjacent human-readable text must display the lot number and expiration date for manual verification. Print quality for pharmaceutical serialization 2D codes requires verification against GS1 Print Quality Guideline specifications.
Child-Resistant Packaging Requirements for Drug Products
The Poison Prevention Packaging Act requires child-resistant packaging for most oral prescription drugs and many OTC drug products. CR packaging must pass PPPA testing protocols: 80% of children under age 5 cannot open the packaging within 5 minutes with visual and tactile cues, and 90% of adults 50 years and older can open and properly reclose the packaging within 5 minutes. CR carton configurations for pharmaceutical packaging use specific structural features that meet PPPA standards. Senior-friendly CR alternatives must satisfy both the child resistance and adult accessibility criteria simultaneously.
Quick Overview
- Products
- 14 types
- Minimum Order
- 100 units
- Production Time
- 2-3 weeks
- Free Shipping
- Yes
Recommended Finishes
Affordable sample kits available
Recommended Box Styles
Popular packaging styles for pharmaceuticals businesses.
Tuck End Boxes
The most versatile folding carton style — tuck flaps on both ends create a clean, secure closure for retail and consumer goods packaging
Sleeve Boxes
Two-piece inner tray and outer sleeve construction creating a controlled sliding reveal for premium product presentation
Folding Cartons
Flat-folded paperboard cartons that erect into boxes at the point of filling — the industry standard for consumer goods retail packaging
Reverse Tuck End Boxes
Tuck end carton where top flap tucks toward the back and bottom flap tucks toward the front — optimized for automated packing lines
Available Finishes
Enhance your pharmaceuticals packaging with premium finishes.
Compliance & Safety
OTC drug packaging must comply with FDA 21 CFR Part 201 (labeling) and 21 CFR Part 211 (GMP for finished pharmaceuticals). Drug Facts panel must comply with 21 CFR Part 201.66. PPPA child-resistant requirements apply to most oral prescription drugs and many OTC categories. DSCSA serialization applies to prescription drug products. State pharmacy board requirements may impose additional packaging obligations.
Pharmaceuticals Packaging FAQs
What FDA labeling is required on pharmaceutical cartons?
OTC drug cartons require the Drug Facts panel in FDA 21 CFR Part 201.66 prescribed format, the principal display panel with product name and net quantity, tamper-evident feature and required tamper-evident statement, lot number and expiration date, and manufacturer information. Prescription drug cartons have different labeling requirements under 21 CFR Part 201 including full prescribing information reference and carton labeling elements specified by the approved NDA or ANDA.
Does pharmaceutical packaging require child-resistant closures?
PPPA requires child-resistant packaging for most oral prescription drugs and many OTC drugs including those containing aspirin, acetaminophen, ibuprofen, and iron above specified thresholds. Senior-friendly CR alternatives are available for some product categories. CR requirements are product-specific -- the PPPA applicability for a specific drug product should be confirmed during packaging specification.
What is DSCSA serialization and does it apply to my product?
DSCSA serialization applies to prescription drug products as defined under the Drug Supply Chain Security Act. Each individual prescription drug saleable unit must bear a product identifier -- a 2D datamatrix barcode encoding the NDC, serial number, lot number, and expiration date. OTC drug products are not subject to DSCSA serialization requirements. Biological products have separate but related serialization requirements.
What board grade is standard for pharmaceutical cartons?
SBS GC1 virgin fiber board is the pharmaceutical carton standard because FDA and EMA regulatory frameworks for drug packaging materials prefer virgin fiber board without recycled content contamination concerns. SBS GC1's consistent surface quality also supports the print registration accuracy required for DSCSA serialization 2D code compliance.
What is the minimum order for custom pharmaceutical packaging?
Our minimum order is 100 units for custom pharmaceutical packaging. FDA Drug Facts panel dieline templates and DSCSA serialization placement specifications are included in the standard setup process for pharmaceutical packaging orders.
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