Home NDC 63102-101-16 ACTINEL
Product NDC 63102-101
Requested package NDC 63102-101-16
11-digit product format 631020101
Labeler code 63102
Product ID 63102-101_11f69bba-6b7f-4876-a8ba-123264408164
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl
Dosage form SOLUTION
Route ORAL
Labeler ACTIPHARMA, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-09-24
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 15; 200; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ACTINEL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL GUAIFENESIN 200 mg/5mL PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1098227 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63102-101-16 ACTINEL 474 mL in 1 BOTTLE SOLUTION 474 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63102-101 ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20240814_db0cb6ae-0a4d-4232-805a-f3f3a058261f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 68 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate SF Menthol Cough Drops MENTHOL WalMart 003a229c-b014-e9f3-e063-6294a90aa5ed 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Cough Drops MENTHOL Walmart 124e6968-f59c-39d4-e063-6294a90a66d4 2025-12-23 Warnings Exact identifier application number: M012 Equate Severe Menthol Throat Drop MENTHOL Walmart 125f3f5a-52aa-e398-e063-6394a90a0012 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Chewable Gels MENTHOL Walmart 1ba4b2be-7242-0a23-e063-6294a90af29c 2025-12-23 Warnings Exact identifier application number: M012 Walgreens Severe Menthol Throat Drops MENTHOL Walgreens 21dd3c68-cbc6-4799-e063-6394a90a6972 2025-12-23 Warnings Exact identifier application number: M012 cherry throat relief lozenges BENZOCAINE Zee Medical 499d0748-538f-678c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 Guaiasorb DM DEXTROMETHORPHAN HBR, GUAIFENESIN NuCare Pharmaceuticals, Inc. 46a480c7-7092-b809-e063-6294a90a60cd 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 360a6304-206d-5475-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 36342d8c-34ab-6178-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Winco Foods 37244333-1307-5121-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco foods 37718c73-880e-4a5c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco Foods 40676ddc-577f-5cc9-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 Sugar Free Menthol Cough Drops MENTHOL Winco Foods 3788e8b6-ab9e-1513-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 SAFETUSSIN Non Drowsy Cough plus chest congestion DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN KRAMER LABORATORIES eeca6370-29ea-4540-8139-e8461d58a286 2025-12-23 Warnings Exact identifier application number: M012 Tussin DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Discount Drug Mart dd31f86b-f59e-459a-8e5f-176828706a4a 2025-12-23 Warnings Exact identifier application number: M012 Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Discount Drug Mart f8e7a08e-7422-4a1b-bfec-93e0b50d10cd 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ae97-7951-4058-e053-2995a90a7b2e 2025-12-23 Warnings Exact identifier application number: M012 Childrens Chest Congestion Relief Grape GUAIFENESIN Discount Drug Mart 3e5d245f-515c-4106-a855-fb97681b646a 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ed16-86bb-3faf-e053-2995a90acfbc 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 2025-12-23 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63102-101-16 63102010116 474 mL in 1 BOTTLE (63102-101-16) 474 ml 2014-09-24 0000-00-00 No No Current