Home NDC 63868-241 Dibromm Cold and Allergy
Product NDC 63868-241
11-digit product format 638680241
Labeler code 63868
Product ID 63868-241_6f5a82da-9dbb-4767-b988-6ed771eb3b57
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine maleate, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-07-31
Substance BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 2; 5 mg/10mL; mg/10mL
Pharmacologic classes Adrenergic alpha1-Agonists [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 Dibromm Cold and Allergy
Brand name suffix Childrens
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 2 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IXA7C9ZN03 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 1053258 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 63868-241-04 Dibromm Cold and AllergyChildrens 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 6 63868-241-04 Dibromm Cold and AllergyChildrens 1 in 1 BOX LIQUID 1 6 63868-241-08 Dibromm Cold and AllergyChildrens 1 in 1 BOX LIQUID 1 6 63868-241-08 Dibromm Cold and AllergyChildrens 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BROMPHENIRAMINE MALEATE ACTIVE INGREDIENT IXA7C9ZN03 DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 BROMPHENIRAMINE ACTIVE MOIETY H57G17P2FN DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-241 DIBROMM COLD AND ALLERGY CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 6 Current NDC, Legacy NDC, 4 package rows 20240423_ea285d5a-9eb4-4f71-bb1b-4e24a8972819.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 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Cherry Cough Drop MENTHOL Safeway Inc. 4a52c0c2-8659-2819-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Cherry Cough Drops MENTHOL Safeway a733e905-af15-d3ea-e053-2a95a90aa7c3 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Honey Lemon Cough Drops MENTHOL Safeway a742449f-c76b-2b91-e053-2a95a90ae4d2 2025-12-20 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE TopCo 60b876e7-c642-5ce8-e053-2a91aa0abd6e 2025-12-20 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Topco Associates 366cc6b1-beff-29d2-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL TopCo Associates 3fef2117-7311-1e66-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Topco Associates 3ff1bf05-e407-3b67-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL Topco Associates 36727f0c-d6d2-28a3-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL Topco Associates 36824bee-607e-7095-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Mixed Berry Sore Throat Lozenges BENZOCAINE Topco Associates 7a00c771-9231-e877-e053-2a91aa0ac96e 2025-12-20 Warnings Exact identifier application number: M012 MUCUS RELIEF GUAIFENESIN 400 MG NUVICARE LLC e25b440e-f389-443f-b333-c66ad1747158 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu severe ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL Wal-Mart Stores Inc 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Geiss, Destin & Dunn Inc. a7d2eaee-484e-43aa-8ae3-0e050219383f 2025-12-19 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Publix 66d8e5f7-9766-57f3-e053-2991aa0a7e17 2025-12-19 Warnings Exact identifier application number: M012 Honey Lemon Cough Drops MENTHOL Publix 66e89fa3-ee09-1d16-e053-2a91aa0ae17c 2025-12-19 Warnings Exact identifier application number: M012 Poly-Vent DM DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL Poly Pharmaceuticals, Inc. 739329ae-0b62-4eab-a07d-867b5d3d61e0 2025-12-19 Warnings Exact identifier application number: M012 Chest Congestion and Cough Relief DM DEXTROMETHORPHAN HBR, GUAIFENESIN ARMY AND AIR FORCE EXCHANGE SERVICE 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 2025-12-19 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63868-241-04 63868024104 1 BOTTLE, PLASTIC in 1 BOX (63868-241-04) / 118 mL in 1 BOTTLE, PLASTIC 2015-07-31 0000-00-00 No No Current 63868-241-08 63868024108 1 BOTTLE, PLASTIC in 1 BOX (63868-241-08) / 237 mL in 1 BOTTLE, PLASTIC 2015-07-31 0000-00-00 No No Current