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 |
|---|---|---|---|---|---|---|
| CVS Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS PHARMACY | 3148f80f-8a0d-4b6c-85be-79085fc04444 | 2026-08-19 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | aa7164a7-f842-457d-abee-0740bb8c1c90 | 2026-08-19 | Warnings | M012 |
| CVS | CHILDRENS STUFFY NOSE AND COLD | CVS PHARMACY, INC | 6cff265d-94a3-4617-a366-fe970d97f05a | 2026-08-19 | Warnings | M012 |
| CVS Severe Congestion and Pain Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS | 5a8e4320-bae1-4831-b66b-9babfe8888d6 | 2026-08-19 | Warnings | M012 |
| CVS Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | CVS PHARMACY | 0ae0c244-e019-4b35-890c-8e15e3d3f7ce | 2026-08-19 | Warnings | M012 |
| CVS Severe Tussin CF Max | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | e32881f5-2bb5-4756-aa86-a09473ab590b | 2026-08-19 | Warnings | M012 |
| Good Sense Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | L. Perrigo Company | d2541ef0-a73c-43aa-91ff-fdbce2748c4f | 2026-08-18 | Warnings | M012 |
| CVS Severe Nasal Congestion Relief Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 5a7e42ee-810c-4bc1-9d8d-fac8e849e126 | 2026-08-18 | Warnings | M012 |
| DAYTIME NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 8dd039b4-209a-484a-b15e-741d55087a93 | 2026-08-18 | Warnings | M012 |
| CVS Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | CVS PHARMACY | 558b7ed6-a9f6-452c-90cd-df8258663bf1 | 2026-08-18 | Warnings | M012 |
| Extra Strength Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | 7acf1a9a-bd97-48bb-8025-ac26070378a2 | 2026-08-18 | Warnings | M012 |
| Polytussin DM | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE | Poly Pharmaceuticals, Inc. | fda8f594-82bf-1781-e053-6294a90ad344 | 2026-08-18 | Warnings | M012 |
| Mucinex Fast-Max DM Max Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | da1f1ef9-a974-4998-8e1d-c1d999596943 | 2026-08-18 | Warnings | M012 |
| CVS Health Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 89168715-71b1-424e-8dae-fcfa90bc85bf | 2026-08-18 | Warnings | M012 |
| CVS Health Sinus | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | c7840511-3a4f-4547-ae90-19b085a5874e | 2026-08-17 | Warnings | M012 |
| CVS Health | NASAL OXYMETAZOLINE HCL | CVS Pharmacy,Inc. | 56f08e70-bf16-4933-97bc-177bc190d12a | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | ALLERGY NASAL | CVS PHARMACY,INC. | 3e76ffac-07a7-4b6a-bc4c-9cabb653e064 | 2026-08-17 | Warnings | M012 |
| CVS dye-free childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY | db5a5eff-1bb1-4d00-8c01-caae7a1c7223 | 2026-08-17 | Warnings | M012 |
| CVS Overnight Cold and Flu Clear and Cool | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | CVS PHARMACY, INC | 2497a011-d7a0-4d69-97e2-bbf25a99b1cc | 2026-08-17 | Warnings | M012 |
| Mucus Relief Cough Cold Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | 3ef949f5-ac8c-44be-b04d-6996fa59a94b | 2026-08-17 | 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 |