Dibromm Cold and Allergy Relief
- Product NDC
- 62011-0443
- Requested package NDC
- 62011-0443-1
- 11-digit product format
- 620110443
- Labeler code
- 62011
- Product ID
- 62011-0443_298ef643-063e-44d1-abd8-de5f6e73d838
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Brompheniramine maleate, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Strategic Sourcing Services LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2019-01-31
- Marketing end
- 0000-00-00
- Substance
- BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 2 mg/10mL; mg/10mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 62011-0443 | 62011-0443-1 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62011-0443-1 | Dibromm Cold and Allergy Reliefchildrens | 1 in 1 BOX | LIQUID | 1 | 3 | |
| 62011-0443-1 | Dibromm Cold and Allergy Reliefchildrens | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62011-0443-1 | ML - Milliliter | 62011-0443 | 07544261-f20f-4add-a417-806694d98388 | 1 | 2021-12-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62011-0443 | DIBROMM COLD AND ALLERGY RELIEF CHILDRENS (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [STRATEGIC SOURCING SERVICES LLC] | 3 | Legacy NDC, 2 package rows | 20240530_61eca862-f9fb-4cf3-9653-b6a7010627dd.zip |
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 | 61eca862-f9fb-4cf3-9653-b6a7010627dd | 3 |
| 1053258 | brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 61eca862-f9fb-4cf3-9653-b6a7010627dd | 3 |
| 1053258 | brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Elixir | SY | 61eca862-f9fb-4cf3-9653-b6a7010627dd | 3 |
| 1053258 | brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 61eca862-f9fb-4cf3-9653-b6a7010627dd | 3 |
| 1053258 | brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 61eca862-f9fb-4cf3-9653-b6a7010627dd | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62011-0443-1 | 62011044301 | 1 BOTTLE, PLASTIC in 1 BOX (62011-0443-1) > 118 mL in 1 BOTTLE, PLASTIC | 2019-01-31 | 0000-00-00 | No | No | Current |