COLTALIN
- Product NDC
- 51467-005
- 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 |
|---|---|---|---|---|---|---|
| Mixed Berry Throat and Cough Lozenges | BENZOCAINE | CVS Pharmacy | 737b1c88-1a44-68cf-e053-2991aa0a35b6 | 2026-01-16 | Warnings | M012 |
| Walgreens Wild Cherry Throat Drops | PECTIN | Walgreens | 4885eca3-c1e9-8350-e063-6394a90ac290 | 2026-01-16 | Warnings | M012 |
| HBP Chest Congestion and Cough Relief | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Walgreens | ff7a1462-9994-4421-85aa-c03488bb04cf | 2026-01-16 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | WALGREEN COMPANY | a793acbc-107c-4638-a2d7-65f4e96cafda | 2026-01-16 | Warnings | M012 |
| MUCUS RELIEF DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Walgreens | ca53ec26-d167-1780-e053-2a95a90a5b88 | 2026-01-16 | Warnings | M012 |
| Maximum Strength Congestion and Headache | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 88da92d2-92c2-445a-9b70-58996e086014 | 2026-01-16 | Warnings | M012 |
| Maximum Strength Cold and Flu | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 5f638bca-55c2-4ead-8c47-3f15713495da | 2026-01-16 | Warnings | M012 |
| COLD, Flu and Sore Throat | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 190175bb-c08a-4050-aacf-29a130cbe05c | 2026-01-16 | Warnings | M012 |
| Night Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | FSA Store Inc. (Caring Mills) | a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff | 2026-01-16 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 99147338-f459-4423-ae54-f96fffc1728d | 2026-01-15 | Warnings | M012 |
| SanaTos Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 144aafcc-6ec2-a322-e063-6294a90afc27 | 2026-01-15 | Warnings | M012 |
| SanaTos Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 14484bf5-ff45-b859-e063-6394a90a9a0f | 2026-01-15 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief PE PE | GUAIFENESIN/PHENYLEPHRINE | Strategic Sourcing Services LLC | 3429aedc-e83d-498a-bfca-03aaf5847b3b | 2026-01-15 | Warnings | M012 |
| Quality Choice Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 4b86101c-00f8-4ede-807f-db4273b37b8d | 2026-01-15 | Warnings | M012 |
| Quality Choice Mucus Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Chain Drug Marketing Association | d1ba7267-6844-4a14-b518-65277a32e855 | 2026-01-15 | Warnings | M012 |
| ACTINEL DM Pediatric | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | f85d8586-423f-48a3-9bb2-bbc5984c7cd3 | 2026-01-15 | Warnings | M012 |
| ACTINEL Diabetic | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | ACTIPHARMA, LLC | 35c21623-84dd-4151-b35b-e7d30b69c9c0 | 2026-01-15 | Warnings | M012 |
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | bdc15c6f-73b4-488e-9134-e70565df71bb | 2026-01-14 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCL 50 MG | DIPHENHYDRAMINE HCL | YYBA Corporation | 4b012549-3958-43c1-9de7-897c5d8b20d3 | 2026-01-14 | Warnings | M012 |
| Rite Aid Pharmacy congestion relief vaporizing steam | VAPORIZING STEAM | Rite Aid Pharmacy | 0fb86b23-0313-8fd8-e063-6394a90a0f5f | 2026-01-14 | 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 |
| 51467-005-02 | 51467000502 | 3 BLISTER PACK in 1 BOX (51467-005-02) / 12 TABLET in 1 BLISTER PACK | 3 blister pack | 2025-07-01 | 2029-06-30 | No | No | Current |