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 | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| Dimetapp Cough and Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 15b0f5ff-202a-d19f-e063-6394a90af2b8 | 2024-04-15 | Warnings | M012 |
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | P & L Development, LLC | 8d27b94d-23a1-4e6c-a064-79e2580f7e2e | 2024-04-15 | Warnings | M012 |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | P & L Development, LLC | 2af496a1-6fdd-4acf-9944-8b7cdf302275 | 2024-04-15 | Warnings | M012 |
| Childrens Dye Free Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | P & L Development, LLC | 1c4d09ed-4e0f-430d-b17f-6a23f996a55d | 2024-04-15 | Warnings | M012 |
| Theraflu ExpressMax Daytime Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 2024-04-10 | Warnings | M012 |
| Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 2024-04-10 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE | Harris Teeter, LLC | ec603195-eb36-4b5c-bc9b-c2074205b2b2 | 2024-04-09 | Warnings | M012 |
| Daytime Cold and Flu Non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 9b0648ac-0ce3-4eaa-8977-26ae864f034d | 2024-04-09 | Warnings | M012 |
| Theraflu Severe Cold Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 2024-04-09 | Warnings | M012 |
| FLONASE Headache and Allergy Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 282c103c-3888-4a35-a5b1-d492ed6892c1 | 2024-04-08 | Warnings | M012 |
| ROBITUSSIN COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 4908b326-e1da-44ca-8087-7e41a16c27b0 | 2024-04-08 | Warnings | M012 |
| Robitussin Direct Sore Throat Pain | ACETAMINOPHEN | Haleon US Holdings LLC | 1b512078-24c3-4b80-8f2c-d6824d367f25 | 2024-04-08 | Warnings | M012 |
| Mucus Relief Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN | H E B | 9ba5ca1b-2e3c-439e-8887-c26f144b88ef | 2024-04-08 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 12ace982-bd47-49b0-ba1b-e0a29d42f1d6 | 2024-04-08 | Warnings | M012 |
| Allergy Childrens | DIPHENHYDRAMINE HYDROCHLORIDE | H E B | ab28cbc4-7a6f-46e9-8616-be78e8cb24fe | 2024-04-08 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | bd19b1f2-d9d3-4dab-8181-605f769ab62f | 2024-04-08 | Warnings | M012 |
| Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 9f533092-060c-4379-9a77-ecfea8aa46e1 | 2024-04-08 | Warnings | M012 |
| Robitussin Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 66360295-f364-479a-8b49-c12b21918279 | 2024-04-06 | Warnings | M012 |
| Robitussin Peak Cold Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 8c0a2424-e8ac-d91c-b46d-a5ee29f91936 | 2024-04-06 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 2024-04-06 | 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 |