Home NDC 63102-110 ACTIDOM DMX
Product NDC 63102-110
11-digit product format 631020110
Labeler code 63102
Product ID 63102-110_07838a85-4ddc-470d-a344-001587f2d904
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler ACTIPHARMA, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-08-13
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 30; 200; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-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-1 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 ACTIDOM DMX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL GUAIFENESIN 200 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 10 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 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1364914 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63102-110-16 ACTIDOM DMX 474 mL in 1 BOTTLE, PLASTIC SOLUTION 474 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63102-110 ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240809_0166322e-7dbb-4658-a5c5-1d0525bb7655.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 71 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAREALL Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc f3b177ef-55d5-4525-bf33-99205c414a5b 2025-12-22 Warnings Exact identifier application number: M012 CAREALL Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc af2f8389-d696-4060-8abd-6eda04e73009 2025-12-22 Warnings Exact identifier application number: M012 BASIC CARE DAYTIME NIGHTTIME SEVERE COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Amazon.com Services LLC 82e68c65-9898-4106-a2f8-e39d124c703e 2025-12-22 Warnings Exact identifier application number: M012 Nighttime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Harris Teeter, LLC 89fd57d2-fe49-41cb-b02e-9643e526cf47 2025-12-22 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Walgreens 464f6645-ca33-1722-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walgreen Co. 47f38e79-c730-21b9-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Walgreen Co. 47522852-005a-2a66-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreens Co, 47653657-80b5-482f-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreen Co. 47f89d33-6e0a-4bb4-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Strawberry Cough Drop MENTHOL 2.7 MG Walgreen Co. 4766afa8-fdaf-05e5-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Menthol Cough Drop MENTHOL Walgreen Co. 477b9fc3-c3c5-647e-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Honey Lemon Cough Drop MENTHOL Walgreen Co. 477cedee-6bd3-2a34-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE Walgreens Co. 47e0f809-0b30-2b23-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Sugar Free Honey Lemon Cough Drops MENTHOL Walgreen 835e276a-493e-1038-e053-2a91aa0a7ea2 2025-12-21 Warnings Exact identifier application number: M012 Walgreens Mixed Berry Benz-Dex Lozenges BENZOCAINE Walgreen e108731f-6b77-225a-e053-2a95a90ac25c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walmart Stores Inc. 318e7acb-0ebb-4518-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Walmart Stores Inc. 316968e1-7715-4caa-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 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 63102-110-16 63102011016 474 mL in 1 BOTTLE, PLASTIC (63102-110-16) 474 ml 2015-08-13 0000-00-00 No No Current