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 |
|---|---|---|---|---|---|---|
| Childrens Mucus Cough and Congestion Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8b5d391b-6c23-44c3-81d0-c08822bf6d01 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Night Time Multi-Symptom Cold | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | e048cd53-a3cd-484f-a972-4cb49791dba3 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cough | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | b8132c81-5291-431a-ad3a-ec8a3eb21c19 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Stuffy Nose and Chest Congestion | GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7354f57c-0ecf-481f-9482-0040c90c4350 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5bda415d-739f-4ca5-b5b2-07c14a81863b | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Multi-Symptom Cold and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8f3eb5c5-832e-4806-b3da-ef112cf55dcf | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE | Reckitt Benckiser LLC | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d9e5a8d7-814c-4ab1-bb05-e4cb9155978e | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack | ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | Reckitt Benckiser LLC | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 84e7be8f-2785-45ef-9c44-de05394fcd99 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 771d7fd8-184f-48a3-90ed-e8f00159d97e | 2026-05-18 | Warnings | M012 |
| MUCINEX Childrens Stuffy Nose | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | de1c0abd-1644-4351-8106-e9df6ca5c142 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Fever Sore Throat and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 1538a75d-582a-9501-e063-6394a90a6c55 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 19105007-0193-0764-e063-6294a90a01a4 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 34fd2458-9acd-cdf7-e063-6394a90a3d0a | 2026-05-18 | Warnings | M012 |
| MUCINEX FAST-MAX NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3a24b06c-00a6-c2ef-e063-6294a90a4d72 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 14be3ab0-d6ae-e342-e063-6294a90ab851 | 2026-05-18 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Bryant Ranch Prepack | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 2026-05-18 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 38df2308-f6f9-4476-ad34-4b5bc5f9fdf2 | 2026-05-18 | Warnings | M012 |
| Allergy Plus Headache Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | 88e3b969-79d0-4e64-95c0-c5cfd41e365f | 2026-05-18 | 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 |