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 98 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Menthol Drops Dollar General Severe Honey Lemon 45ct MENTHOL Dollar General Corporation 0ea61a4c-690a-4349-9952-cc17fb1f0671 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Dollar General Menthol 30ct MENTHOL Dollar General Corporation 892092cc-5a1c-4309-baf9-a040888d3577 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Dollar General Menthol 80ct MENTHOL Dollar General Corporation 773f4ad2-6c91-431f-ad3d-c0e53e7ca918 2025-10-08 Warnings Exact identifier application number: M012 Menthol Drops Dollar General Severe 45ct MENTHOL Dollar General Corporation 13c7d3b1-12ac-4931-877c-728d3d89942c 2025-10-08 Warnings Exact identifier application number: M012 Menthol Drops Dollar General Severe Honey Lemon 45ct MENTHOL Dollar General Corporation d0c878f0-a737-4583-9847-834af70e7d6f 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Freegells Strawberry 30ct MENTHOL R.L. ALBERT & SON, INC dc077c36-c403-4b83-894a-e9922e928841 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Freegells Strawberry 30ct MENTHOL RL Albert & Son Inc. 2ea760f3-df50-4c46-a43d-d5ed07f421a5 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Honey Lemon 200ct MENTHOL RL Albert & Son Inc. 3ac08274-08d9-4dab-b09a-6e297948a25a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Honey Lemon 30ct MENTHOL RL Albert & Son Inc. 8114e1a2-728d-4489-a494-f28a5e7d9bb3 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 30ct MENTHOL RL Albert & Son Inc. 0c2e594a-cdf8-4595-bda6-0ebc19ac3850 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 200ct MENTHOL R.L. ALBERT & SON, INC f62b7f75-3275-46c9-880c-64148d0dce59 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL R.L. ALBERT & SON, INC 15917bfb-f660-4a12-bdcc-5b4a96e0e1d0 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL RL Albert & Son Inc. 92c54c53-c8bb-4576-abae-715a2f3878bf 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL RL Albert & Son Inc. c96cc162-5908-4990-9dc1-3ce912844274 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL R.L. ALBERT & SON, INC bac77712-6197-4b30-a5f8-9b99eb9d7b5a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL R.L. ALBERT & SON, INC 6842d766-ade6-40b2-831b-f4feac25c6db 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL RL Albert & Son Inc. 9f324ca1-0e2a-47e3-997e-2aaa68a85751 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 30ct MENTHOL R.L. ALBERT & SON, INC 2063a013-aa0b-465d-b04f-cfe2e70d749f 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 200ct MENTHOL R.L. ALBERT & SON, INC cd81488c-74d8-48d9-9c73-ff662a5cd4cd 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 80ct MENTHOL R.L. ALBERT & SON, INC 61deea94-d0a9-4563-926b-53f255a7c425 2025-10-08 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