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 |
|---|---|---|---|---|---|---|
| Walgreens NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | WALGREEN COMPANY | 5bf72e2f-15c8-466a-9e13-50654233da91 | 2026-01-19 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | 9862f84d-1c18-4ef7-86dc-98572599d417 | 2026-01-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 37853689-c9ca-4bc7-9c5b-4a68b8d778be | 2026-01-19 | Warnings | M012 |
| VAPORX | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | AKRON PHARMA INC | 51b32162-0c5a-4b5b-999a-34337d816603 | 2026-01-19 | Warnings | M012 |
| Equate | OXYMETAZOLINE HCL | Walmart Inc | 2f762c24-2442-506a-e063-6394a90a3b96 | 2026-01-19 | Warnings | M012 |
| Dimetane | DIPHENHYDRAMINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 2026-01-19 | Warnings | M012 |
| nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | f681d986-9838-42d8-8ed9-732a39fbf870 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | H E B | 22d241c5-a3fd-4619-8147-91d7a4c8cf98 | 2026-01-19 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | Better Living Brands, LLC | 9fe63ca6-3863-4175-9aec-ecd6ebbdb249 | 2026-01-19 | Warnings | M012 |
| Good Neighbor Pharmacy Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | 5749ce9d-e182-478f-ab88-b520a35a99a7 | 2026-01-19 | Warnings | M012 |
| Foster and Thrive Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Strategic Sourcing Services LLC | 1d9150b1-2f6c-4c33-8c93-3ed1d88585e2 | 2026-01-18 | Warnings | M012 |
| HealthWise Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | ce3ceffd-3ff5-3795-e053-2995a90a827f | 2026-01-18 | Warnings | M012 |
| topcare nite time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Topco Associates LLC | 31210a95-f9dc-49db-aab5-25c4dca49266 | 2026-01-17 | Warnings | M012 |
| Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f77226c0-b6d5-9fd0-e053-6294a90a4b57 | 2026-01-16 | Warnings | M012 |
| Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f691734b-5cf4-6eb8-e053-2a95a90aee80 | 2026-01-16 | Warnings | M012 |
| Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Procter & Gamble Manufactura S de RL de CV | f771aa19-295a-9f4e-e053-6294a90a1674 | 2026-01-16 | Warnings | M012 |
| CVS Cherry Cough Drops | MENTHOL | CVS Pharmacy | de5c4b94-0420-5d43-e053-2995a90aa5a5 | 2026-01-16 | Warnings | M012 |
| CVS Honey Lemon Cough Drops | MENTHOL | CVS Pharmacy | de963dc3-8108-440f-e053-2995a90a906f | 2026-01-16 | Warnings | M012 |
| CVS SF Menthol Cough Drops | MENTHOL | CVS Pharmacy | e08f8ca3-b683-4964-e053-2a95a90afabb | 2026-01-16 | Warnings | M012 |
| CVS SF Honey Lemon Cough Drops | MENTHOL | CVS Pharmacy | e0cdeccf-c32f-318a-e053-2a95a90ac401 | 2026-01-16 | 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 |