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 |
|---|---|---|---|---|---|---|
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0bf911bf-eafe-fe46-e063-6294a90a3903 | 2024-07-03 | Warnings | M012 |
| Family Wellness Effervescent Cold Relief Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Family Dollar Services, Inc. | 4e13511b-fbb5-2523-e054-00144ff88e88 | 2024-07-03 | Warnings | M012 |
| Nighttime Cherry Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | TARGET CORPORATION | 1c3f6cbf-a00d-45b9-e063-6394a90a797c | 2024-07-02 | Warnings | M012 |
| Cold Terminator Cold Relief | PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Wildman Business Group | e8538d9c-f9ba-40b1-b60f-f57921f39b64 | 2024-07-01 | Warnings | M012 |
| Nighttime Severe Honey Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1c02e465-8750-a088-e063-6394a90a8efb | 2024-06-29 | Warnings | M012 |
| ACTIDOM DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 0166322e-7dbb-4658-a5c5-1d0525bb7655 | 2024-06-28 | Warnings | M012 |
| ACTINEL DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | ACTIPHARMA, LLC | 16660d82-524b-42ca-8581-48237caa13b2 | 2024-06-28 | Warnings | M012 |
| PurgenLabs Acetaminophen | ACTAMINOPHEN | Advanced Rx LLC | 915c4608-af1b-4119-8291-4ce9fd701d76 | 2024-06-28 | Warnings | M012 |
| Daytime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL | TARGET CORPORATION | 1bc90b2f-612c-e977-e063-6294a90a40b4 | 2024-06-26 | Warnings | M012 |
| Halls Mentholyptus | MENTHOL | Mondelez Global LLC | f5292c5b-5608-4e13-afc2-4f3d7133da88 | 2024-06-25 | Warnings | M012 |
| Halls Strawberry | MENTHOL | Mondelez Global LLC | 75638f29-7f2a-46b0-b8a0-e87bc7d6eba1 | 2024-06-25 | Warnings | M012 |
| Good Sense Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | A-S Medication Solutions | 5396a9cf-16eb-4628-9432-f49c67ffe2ce | 2024-06-25 | Warnings | M012 |
| Nighttime Cold and Flu Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 130ca5f1-2951-ec6f-e063-6394a90a754f | 2024-06-24 | Warnings | M012 |
| Daytime and Nighttime Severe Honey Cold and Flu | DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 08fd1513-30ab-15da-e063-6394a90ab57d | 2024-06-21 | Warnings | M012 |
| Daytime Severe and Nighttime Severe cold and flu | DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 0c0caa59-0637-bc33-e063-6294a90ae244 | 2024-06-21 | Warnings | M012 |
| Halls Strawberry | MENTHOL | Mondelez Global LLC | de401eb4-3282-4298-8a51-15d268253464 | 2024-06-21 | Warnings | M012 |
| Cough and Chest Congestion DM Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreens | e4515d0e-c12b-40cd-8218-6d91476cfebd | 2024-06-21 | Warnings | M012 |
| SUDOGEST | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 1811199f-bf88-475f-8f94-b372db4bead3 | 2024-06-20 | Warnings | M012 |
| Theraflu Severe Cold Relief Soft Chews | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 91dbb541-6a86-4803-a1fe-1bf61b457c34 | 2024-06-19 | Warnings | M012 |
| Tukol Max Action Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | aedce1f9-4902-4c51-92e0-6056196394c2 | 2024-06-14 | 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 |