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 Relief Cough Cherry Liquid | DEXTROMETHORPHAN HBR, GUAIFENSIN | Topco Associates | 3170748e-b09f-4c07-9927-df43771166c5 | 2025-12-16 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe | 2025-12-16 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | e70d0784-53bc-4910-aade-3c9ad6e36441 | 2025-12-16 | Warnings | M012 |
| Pain and Sinus | ACETAMINOPHEN AND PHENYLEPHRINE | JHK Inc dba American Safety & First Aid | 88f86f5a-cc2b-4c75-b7a4-f2021922280b | 2025-12-16 | Warnings | M012 |
| Severe Congestion and Cough, Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | Walgreen Company | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 2025-12-16 | Warnings | M012 |
| Cough Relief Nighttime | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fe5fd29e-7f81-4633-8c3b-010d68abe701 | 2025-12-16 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | e0a62fa1-9f8a-4770-b28b-1f4f02a762e0 | 2025-12-16 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 8c4b59b8-dfab-4f4a-9966-f07b026a758a | 2025-12-16 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | QUALITY CHOICE (Chain Drug Marketing Association) | df866cf6-0526-4e61-ac9b-245b57dd5df6 | 2025-12-16 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | c89200b6-4adb-452e-b931-07f631dad641 | 2025-12-16 | Warnings | M012 |
| ONESSIP ADULT DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | MEDWISE LIFESCIENCES INC. | 45fa9159-d74c-063a-e063-6294a90a3ed0 | 2025-12-15 | Warnings | M012 |
| SudoGest Nasal Decongestant | PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | 5229f4b2-a194-46f8-a0bc-4510fbe52075 | 2025-12-15 | Warnings | M012 |
| Topcare Nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | f2b2467f-2d9b-4742-b90a-95975c3b694f | 2025-12-13 | Warnings | M012 |
| Menthol Cough Drop | MENTHOL | HEB | 39178eb7-ada9-30bf-e054-00144ff88e88 | 2025-12-13 | Warnings | M012 |
| SF Menthol Cough Drop | MENTHOL | HEB | 3a443179-b7a6-3242-e054-00144ff8d46c | 2025-12-13 | Warnings | M012 |
| Cherry cough drop | MENTHOL | HEB | 39bd0ca1-348f-0ce1-e054-00144ff88e88 | 2025-12-13 | Warnings | M012 |
| Strawberry Cough Drops | MENTHOL | HEB | 766236e2-3302-2232-e053-2991aa0af503 | 2025-12-13 | Warnings | M012 |
| Honey Lemon Cough Drop | MENTHOL | HEB | 3a30a427-6ab4-24ae-e054-00144ff88e88 | 2025-12-13 | Warnings | M012 |
| Mixed Berry Sore Throat and Cough Lozenges | BENZOCAINE | HEB | 3063ea93-6bc2-1d18-e054-00144ff88e88 | 2025-12-13 | Warnings | M012 |
| HEB Menthol Cough Drops | MENTHOL | HEB | c197855d-15b4-38fc-e053-2a95a90a2dc7 | 2025-12-13 | 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 |