Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate
- Product NDC
- 51316-609
- 11-digit product format
- 513160609
- Labeler code
- 51316
- Product ID
- 51316-609_41b206d7-e021-f8e0-e063-6394a90ad0e1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- CVS Pharmacy, Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-05
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 51316-609 | 51316-609-07 | D | Discontinued by firm | 2026-10-23 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51316-609 | 51316-609-07 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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
- Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1532ee21-e114-ded7-e063-6294a90ab025 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-604-05 | Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | 6 in 1 PACKET | POWDER | 6 in 12 | 30 mg | 2 |
| 51316-605-05 | Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | 6 in 1 PACKET | POWDER | 6 in 12 | 4 mg | 2 |
| 51316-609-07 | Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | 1 in 1 CARTON | KIT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Severe Sinus Relief Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 847f47d9-62b1-49a3-8bb3-9bf275685bd2 | 2024-02-14 | Warnings | M012 |
| Allergy Sinus, Lil Drug Store | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE | Lil' Drug Store Products, Inc. | 1145440e-b37a-6e5e-e063-6294a90ab4a0 | 2024-02-13 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | A-S Medication Solutions | 36140639-e7a8-43bc-83e2-469430af9d1a | 2024-02-13 | Warnings | M012 |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | ff48b55a-0d32-47d6-941d-d99c7cf52f94 | 2024-02-12 | Warnings | M012 |
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 15950273-14c9-4a0b-bbb4-683048add722 | 2024-02-08 | Warnings | M012 |
| THERAFLU Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7d902237-a990-4c5e-875b-291e124e143b | 2024-02-03 | Warnings | M012 |
| Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 0f2d371d-f890-41e5-ac11-db5559d32466 | 2024-02-02 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 4daca846-8511-4303-9e6c-9469f7f260ba | 2024-02-02 | Warnings | M012 |
| CVS Health COUGH SUPPRESSANT SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE | CVS Pharmacy, Inc. | f676dfeb-fba8-419d-8a47-c3880e4100cc | 2024-02-02 | Warnings | M012 |
| Nighttime Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 155a7168-b568-41f4-b8a2-214889b4eccf | 2024-02-02 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | Rejoice International Corp. | 104e1a38-3472-b9e2-e063-6294a90a38cf | 2024-02-01 | Warnings | M012 |
| Vaporizing Chest Rub Lavender 4oz | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 104f5b07-eed2-566c-e063-6294a90a6505 | 2024-02-01 | Warnings | M012 |
| CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 5962a73e-72e4-493b-94a7-43bc6cf9c82f | 2024-02-01 | Warnings | M012 |
| good sense allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | L. Perrigo Company | 2cfa69b4-e33f-442a-a6df-b021b041da14 | 2024-02-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2024-01-31 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 17a07d2d-f2da-4e51-9a77-6f0c174987bb | 2024-01-31 | Warnings | M012 |
| Maximum strength Max Cold and Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 2024-01-31 | Warnings | M012 |
| THERAFLU POWERPODS NIGHTTIME SEVERE COLD | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 39f9feef-4bf2-4f10-9fff-22bbb1d8a471 | 2024-01-30 | Warnings | M012 |
| Theraflu Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | c0689223-5c90-4dbc-bbfa-f94e267504c3 | 2024-01-28 | Warnings | M012 |
| THERAFLU MULTI-SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | a4c56ca0-7785-404b-996d-137cc135f270 | 2024-01-28 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2636659 | {1 (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } Pack | GPCK | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636659 | {1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } Pack | PSN | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral Solution | PSN | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636656 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | PSN | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SCD | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636656 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SCD | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636659 | {1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) } Pack | SY | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636658 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution | SY | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636656 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution | SY | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636658 | APAP 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SY | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
| 2636656 | APAP 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution | SY | 1532ee21-e114-ded7-e063-6294a90ab025 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 51316-604-05 | 51316060405 | 6 in 1 PACKET | Historical |
| 51316-605-05 | 51316060505 | 6 in 1 PACKET | Historical |
| 51316-609-07 | 51316060907 | 1 in 1 CARTON | Historical |