COLTALIN-DM
- Product NDC
- 51467-012
- 11-digit product format
- 514670012
- Labeler code
- 51467
- Product ID
- 51467-012_5bb2b1bb-0b8f-02a6-e063-6294a90a0763
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, 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; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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-DM
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1086991 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 33e1bec0-323b-40b7-809a-cb65a71ad0ce | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51467-012-01 | COLTALIN-DM | 2 in 1 BOX | TABLET | 2 | 3 | |
| 51467-012-01 | COLTALIN-DM | 12 in 1 BLISTER PACK | TABLET | 12 | 3 | |
| 51467-012-02 | COLTALIN-DM | 3 in 1 BOX | TABLET | 3 | 3 | |
| 51467-012-02 | COLTALIN-DM | 12 in 1 BLISTER PACK | TABLET | 12 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51467-012 | COLTALIN-DM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | Current NDC, 4 package rows | 20241228_33e1bec0-323b-40b7-809a-cb65a71ad0ce.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 |
|---|---|---|---|---|---|---|
| Freegells Cough Drops Menthol Honey Lemon | MENTHOL | Riclan S.A. | f6271e85-9ca2-41d3-9bff-a13670ac5b80 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Strawberry | MENTHOL | Riclan S.A. | da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 | 2023-10-26 | Warnings | M012 |
| DG Health Cough Drops Assorted Flavors | MENTHOL | Dollar General Corporation | c731d255-40f2-3cb3-e053-2a95a90a8877 | 2023-10-26 | Warnings | M012 |
| ALKA SELTZER PLUS Cold Day and Night Effervescent | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Sincronia Logistica, S.A. de C.V. | c478df69-823a-4112-8f44-323249a9f38f | 2023-10-23 | Warnings | M012 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 169006cb-7dc2-4113-a289-0b1f14e784b7 | 2023-10-23 | Warnings | M012 |
| Night-Time Cold and Flu Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | HealthLife of USA | 2ffd62a6-703f-4cb0-bb13-49719c004d00 | 2023-10-21 | Warnings | M012 |
| Day-Time Cold and Flu Relief | ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN | HealthLife of USA | c5f6cf22-2aaa-40e1-b7b3-448e55898d62 | 2023-10-21 | Warnings | M012 |
| PENTREXCILINA | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Healthlife of USA | ae9ada14-0ec8-4c01-a874-237f2108936a | 2023-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | APNAR PHARMA LP | e5004c10-3877-c199-e053-2a95a90aa8ac | 2023-10-21 | Boxed warning, Warnings | M012 |
| Day and Night Multi Symptom Cold and Flu Relief | DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF | Intrivo Diagnostics Inc. | a311bf39-de6c-4ed5-949e-718ad8be1e49 | 2023-10-13 | Warnings | M012 |
| Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 2023-10-10 | Warnings | M012 |
| Triacting Daytime Cold Cough Childrens | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8656aa2e-9546-4de4-9ecc-ce99bf903333 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL | Walgreens | a33ae35b-1cde-4a3d-a836-3b169e4f1bb9 | 2023-10-10 | Warnings | M012 |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 553d01a9-e8ad-4797-b55b-32f134f08af9 | 2023-10-10 | Warnings | M012 |
| Mucus Relief Maximum StrengthCold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 8781e2c5-ad46-4615-a0d9-879590e86f95 | 2023-10-10 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 419df833-1f33-45cf-bab3-730c928d5887 | 2023-10-10 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 93a5cb36-3262-4224-a5be-5ea1619a67bd | 2023-10-10 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | CVS Pharmacy | 782fb103-cd9f-4e8c-8f3a-1fb131b9eda6 | 2023-10-09 | Warnings | M012 |
| Cold and Congestion Childrens Nighttime | DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL | Walgreens | a7847413-e556-4f88-8a7f-a8528afbe927 | 2023-10-09 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | 06d2c6cf-0adb-91b9-e063-6294a90aff52 | 2023-10-03 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 33e1bec0-323b-40b7-809a-cb65a71ad0ce | 3 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 33e1bec0-323b-40b7-809a-cb65a71ad0ce | 3 |
| 1086991 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 33e1bec0-323b-40b7-809a-cb65a71ad0ce | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51467-012-01 | 51467001201 | 2 BLISTER PACK in 1 BOX (51467-012-01) / 12 TABLET in 1 BLISTER PACK | 2 blister pack | 2025-07-01 | 2029-06-30 | No | No | Historical |
| 51467-012-02 | 51467001202 | 3 BLISTER PACK in 1 BOX (51467-012-02) / 12 TABLET in 1 BLISTER PACK | 3 blister pack | 2025-07-01 | 2029-06-30 | No | No | Historical |