COLTALIN
- Product NDC
- 51467-005
- Requested package NDC
- 51467-005-01
- 11-digit product format
- 514670005
- Labeler code
- 51467
- Product ID
- 51467-005_5ba08310-092e-cbe0-e063-6294a90a73a1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- FORTUNE PHARMACAL COMPANY LIMITED
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-01
- Marketing end
- 2029-06-30
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 2; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- 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
- COLTALIN
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51467-005-01 | COLTALIN | 12 in 1 BLISTER PACK | TABLET | 12 | 13 | |
| 51467-005-01 | COLTALIN | 2 in 1 BOX | TABLET | 2 | 13 | |
| 51467-005-02 | COLTALIN | 12 in 1 BLISTER PACK | TABLET | 12 | 13 | |
| 51467-005-02 | COLTALIN | 3 in 1 BOX | TABLET | 3 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51467-005 | COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 11 | Current NDC, Legacy NDC, 4 package rows | 20241121_01ab1152-06c9-4afe-8f2a-e110365275a5.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 |
|---|---|---|---|---|---|---|
| ACTIDOGESIC | DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN | ACTIPHARMA, LLC | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 2025-08-18 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0 | 2025-08-18 | Warnings | M012 |
| MAJOR NASAL DECONGESTANT | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | 4b78b9af-0975-43f8-8b44-daddef0478be | 2025-08-15 | Warnings | M012 |
| Dr Simi Mucus Relief Expectorant | GUAIFENESIN | Farmacias De Similares TX LLC | 3c6d0e75-a685-6020-e063-6294a90a5c1b | 2025-08-15 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 25bf4390-23f7-4bb6-b86e-c40eaf8d92da | 2025-08-15 | Warnings | M012 |
| Childrens Chewable Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2cac72be-4830-ad49-e063-6394a90a7832 | 2025-08-14 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AMERISOURCE BERGEN | 2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e | 2025-08-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walmart Inc. | 16fae164-28db-8ef1-e063-6294a90ab5da | 2025-08-12 | Warnings | M012 |
| Exchange Select Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fbece335-a7e5-4732-a086-561b23741579 | 2025-08-12 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 779ddb89-b6e2-4bfb-bcb5-8c7ec916675a | 2025-08-12 | Warnings | M012 |
| Equaline Nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | d7fa1720-eac4-4e82-9401-77215ce4f545 | 2025-08-12 | Warnings | M012 |
| Diabetic Tussin DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | MEDTECH PRODUCTS INC | a10a3b33-7503-4334-8ed7-2bb881df4327 | 2025-08-08 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health, Inc | 26a55d74-f772-5d17-e063-6394a90a5583 | 2025-08-07 | Warnings | M012 |
| Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | b7434978-44a8-4c51-979d-0bc446461e43 | 2025-08-06 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | fc1e224c-5c57-43fc-ae6e-36aa0a4ae439 | 2025-08-06 | Warnings | M012 |
| childrens cold cough dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Publix Super Markets Inc | 6efe7097-2a99-4654-9d94-b47f2e64d19d | 2025-08-05 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Chain Drug Marketing Association, Inc. | 3b7548ee-7cd3-62c3-e063-6294a90a0612 | 2025-08-03 | Warnings | M012 |
| Vaporizing chest rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | LJ Pharma | 065bb666-e482-4e96-ac75-c6577dcc5b48 | 2025-08-01 | Warnings | M012 |
| Nighttime Cough-Kids | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Genexa | 024bb864-4214-1d8b-e063-6394a90aa573 | 2025-08-01 | Warnings | M012 |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Pharmadel LLC | 3b53e5fc-f258-c2b9-e063-6394a90ab500 | 2025-08-01 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1046781 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 01ab1152-06c9-4afe-8f2a-e110365275a5 | 13 |
| 1046781 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 01ab1152-06c9-4afe-8f2a-e110365275a5 | 13 |
| 1046781 | APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 01ab1152-06c9-4afe-8f2a-e110365275a5 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51467-005-01 | 51467000501 | 2 BLISTER PACK in 1 BOX (51467-005-01) / 12 TABLET in 1 BLISTER PACK | 2 blister pack | 2025-07-01 | 2029-06-30 | No | No | Current |