EXTRA FAST COLTALIN
- Product NDC
- 51467-014
- 11-digit product format
- 514670014
- Labeler code
- 51467
- Product ID
- 51467-014_5bb2dabb-4450-346f-e063-6294a90a0c67
- 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
- EXTRA FAST 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 |
|---|---|---|---|---|---|---|
| 51467-014-01 | EXTRA FAST COLTALIN | 2 in 1 BOX | TABLET | 2 | 3 | |
| 51467-014-01 | EXTRA FAST COLTALIN | 12 in 1 BLISTER PACK | TABLET | 12 | 3 | |
| 51467-014-02 | EXTRA FAST COLTALIN | 12 in 1 BLISTER PACK | TABLET | 12 | 3 | |
| 51467-014-02 | EXTRA FAST COLTALIN | 3 in 1 BOX | TABLET | 3 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51467-014 | EXTRA FAST COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | Current NDC, 4 package rows | 20241228_1a28fea6-095f-4488-92aa-e6bd8908e17b.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 |
|---|---|---|---|---|---|---|
| TheraCare Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | d6e789c7-a55a-dc9a-e053-2a95a90a2bdb | 2024-10-29 | Warnings | M012 |
| Careone daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | American Sales Company | 31187c98-6706-4962-91f6-022a390cda39 | 2024-10-28 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 0100f86e-257f-4197-9849-3c4429cdf0f2 | 2024-10-28 | Warnings | M012 |
| Premier Value Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | PHARMACY VALUE ALLIANCE LLC | 46bf124a-a44f-4066-b936-852d46da8f40 | 2024-10-28 | Warnings | M012 |
| Signature Care Non drowsy Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway | 25a26577-a9f8-49cb-9d75-d8c471e4aaf6 | 2024-10-28 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e | 2024-10-28 | Warnings | M012 |
| Leader Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | d38537c6-9553-4e93-a83e-11ed48c955ab | 2024-10-28 | Warnings | M012 |
| Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 2b3a1997-f382-4843-a44b-d80d1ad21a90 | 2024-10-28 | Warnings | M012 |
| Premier Value Tussin Cough Long Acting | DEXTROMETHORPHAN HBR | Chain Drug Consortium, LLC | 0e393287-5bb8-458b-98c4-55fa16674d06 | 2024-10-28 | Warnings | M012 |
| daytime cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 1740ccfc-6e68-46f4-a1ba-48fe092f0aa0 | 2024-10-28 | Warnings | M012 |
| night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | d3bd0632-328c-4ad7-bb44-8383e1e51b8c | 2024-10-28 | Warnings | M012 |
| Premier Value | DEXTROMETHORPHAN HBR, GUAIFENESIN | PHARMACY VALUE ALLIANCE LLC | 1ae3c6ac-1646-4c67-a9d5-9c383924b81a | 2024-10-28 | Warnings | M012 |
| nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 2024-10-25 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | b6d9f421-b236-4660-be7f-85a878f2fc61 | 2024-10-25 | Warnings | M012 |
| COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Chain Drug Consortium, LLC | f9c3c12b-4efa-4ec4-a156-c403aff81753 | 2024-10-24 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Chain Drug Consortium, LLC | 1deb60f3-e9be-4756-b0c1-527ef00dc741 | 2024-10-24 | Warnings | M012 |
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | 51dd467b-aae8-41fa-e054-00144ff8d46c | 2024-10-24 | Warnings | M012 |
| Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 68a5930b-37db-439d-8fb9-7d7de07d8465 | 2024-10-24 | Warnings | M012 |
| sinus pressure pain and cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | bb0225d5-6c32-2c64-e053-2995a90a829b | 2024-10-24 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148 | 2024-10-24 | 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 | 1a28fea6-095f-4488-92aa-e6bd8908e17b | 3 |
| 1046781 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1a28fea6-095f-4488-92aa-e6bd8908e17b | 3 |
| 1046781 | APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1a28fea6-095f-4488-92aa-e6bd8908e17b | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51467-014-01 | 51467001401 | 2 BLISTER PACK in 1 BOX (51467-014-01) / 12 TABLET in 1 BLISTER PACK | 2 blister pack | 2025-07-01 | 2029-06-30 | No | No | Historical |
| 51467-014-02 | 51467001402 | 3 BLISTER PACK in 1 BOX (51467-014-02) / 12 TABLET in 1 BLISTER PACK | 3 blister pack | 2025-07-01 | 2029-06-30 | No | No | Historical |