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 |
|---|---|
| BROMPHENIRAMINE MALEATE | 2 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| IXA7C9ZN03 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1053258 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ea285d5a-9eb4-4f71-bb1b-4e24a8972819 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-241-04 | ML - Milliliter | 63868-241 | fc8bbbfe-d36c-4038-963c-bce9caf04147 | 1 | 2022-09-12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxymetazoline hydrochloride | OXYMETAZOLINE HYDROCHLORIDE | Prodose, Inc. | 3dce34f0-9f6d-8151-e063-6394a90a1d38 | 2026-02-11 | Warnings | M012 |
| SIGNATURE CARE Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | SAFEWAY | 831da7b6-25c7-4601-b7f1-1800a238b016 | 2026-02-11 | Warnings | M012 |
| Allergy Plus Congestion Relief | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0d2cf481-622f-4262-b0bd-c38fe5de6721 | 2026-02-11 | Warnings | M012 |
| Sinus and Headache Daytime | ACETAMINOPHEN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | 869e950c-5861-4840-aaad-b0342790d62b | 2026-02-10 | Warnings | M012 |
| CareOne Night TIme Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25 | 2026-02-10 | Warnings | M012 |
| Medique Cold Cough Product | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , | Sportpharm LLC | d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9 | 2026-02-09 | Warnings | M012 |
| Sinus Congestion and Pain Daytime | ACETAMINOPHEN AND PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | f3fc270a-92fc-46d5-b187-44e875c3abb9 | 2026-02-09 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | d5c8b248-6d82-4eac-881c-0b9d0a0de8f1 | 2026-02-09 | Warnings | M012 |
| DayTime/NiteTime Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | d07112dd-27df-46cc-b7c3-af8ba7601d06 | 2026-02-09 | Warnings | M012 |
| TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 48f7933e-6582-638c-e063-6394a90abfe5 | 2026-02-06 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Retail Business Services, LLC | 4fb46860-2bf9-41a7-89eb-31c259c61107 | 2026-02-06 | Warnings, Adverse reactions | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | Sportpharm LLC | 909dacfa-50d3-4bcf-b2df-5405427cfaad | 2026-02-06 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | Sportpharm LLC | f91b7c1f-e074-4767-b9c8-dbf1937a6a0f | 2026-02-06 | Warnings | M012 |
| Severe Allergy And Sinus Headache Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy | b3c744b8-aa93-505d-f8cf-07995da4283d | 2026-02-06 | Warnings | M012 |
| NightTime Cold and Flu Multi Symptom | ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 911e6a51-c0f0-491a-b70c-00011ed5e35b | 2026-02-06 | Warnings | M012 |
| Severe Sinus Daytime, Non-Drowsy | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | cc0dc951-5024-4517-9d38-a01699407e7e | 2026-02-06 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Pharmacy Value Alliance, LLC | d836c3e2-3b69-41f3-b166-21270550e8ab | 2026-02-05 | Warnings, Adverse reactions | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Publix Super Markets, Inc. | 81b1d5bb-f813-4f79-9559-2494db33ad3c | 2026-02-05 | Warnings, Adverse reactions | M012 |
| Nasal | OXYMETAZOLINE HYDROCHLORIDE | Kroger Company | 6499f854-2995-48cb-9c80-be6524b3db43 | 2026-02-05 | Warnings | M012 |
| Cold and Flu plus Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALMART INC. | 52a398eb-e593-458b-9c42-6f653ca391be | 2026-02-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1053258 | brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | ea285d5a-9eb4-4f71-bb1b-4e24a8972819 | 6 |
| 1053258 | brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | ea285d5a-9eb4-4f71-bb1b-4e24a8972819 | 6 |
| 1053258 | brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Elixir | SY | ea285d5a-9eb4-4f71-bb1b-4e24a8972819 | 6 |
| 1053258 | brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | ea285d5a-9eb4-4f71-bb1b-4e24a8972819 | 6 |
| 1053258 | brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | ea285d5a-9eb4-4f71-bb1b-4e24a8972819 | 6 |
Packages#
| 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 |