Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
- Product NDC
- 69729-782
- 11-digit product format
- 697290782
- Labeler code
- 69729
- Product ID
- 69729-782_5c3f62d2-aa68-6733-e063-6394a90a186a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-02-18
- Substance
- ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 200; 10; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 69729-782-10 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 69729-782-10 | 1332a3947898… | d4bfe170f9cd… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 69729-782-10 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 69729-782-10 | bd6a592717d7… | 303034d00443… |
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, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-782-10 | Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 4 |
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 |
|---|---|---|---|---|---|---|
| Cold Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 077fac1a-0ec5-40d9-8861-a281b48f650a | 2026-09-08 | Warnings | M012 |
| Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | RARITAN PHARMACEUTICALS | eef00453-9f4f-4a05-bb4e-49b94705b52c | 2026-09-08 | Warnings | M012 |
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | RARITAN PHARMACEUTICALS INC | 9819155b-2713-42be-867e-16605e7643d0 | 2026-09-08 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | WALMART INC. | f9d1dfd1-527f-491d-9188-14886ac70ced | 2026-09-08 | Warnings | M012 |
| severe cold and cough daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | RARITAN PHARMACEUTICALS INC | 3ce8508e-7d9d-4413-858a-8f952e760c01 | 2026-09-08 | Warnings | M012 |
| Multi Symptom Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | RARITAN PHARMACEUTICALS INC | d9606c9a-31b1-4121-9870-809a05f5b68a | 2026-09-08 | Warnings | M012 |
| Mucus Relief DM Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | RARITAN PHARMACEUTICALS INC | 4898b1c2-55ef-4589-982b-2279c01707e5 | 2026-09-08 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association, Inc. | 2a7afe03-3c34-4e30-827e-b3bb2568cb97 | 2026-09-08 | Warnings | M012 |
| tabcin Extra Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | OPMX LLC | 23223821-4fa0-5d99-e063-6394a90af0e5 | 2026-09-07 | Warnings | M012 |
| Drx Choice childrens allergy chews | DIPHENHYDRAMINE HCL | RARITAN PHARMACEUTICALS INC | dd2be906-bd0a-437c-9693-54b9391a5da3 | 2026-09-05 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 49235f4f-e661-4a83-88ef-b9a956848777 | 2026-09-04 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | 71845bf9-8981-4ca0-a62c-dbef102b1b02 | 2026-09-04 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 774d2bde-9f57-4ced-800a-cada39c685ed | 2026-09-04 | Warnings | M012 |
| Nostrilla | OXYMETAZOLINE HYDROCHLORIDE | Insight Pharmaceuticals LLC | 86217847-8e2b-48cc-b289-4987fd3aa7c3 | 2026-09-04 | Warnings | M012 |
| tussin cough chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rite Aid Corporation | 86fc3723-5fc5-4de5-bd04-7774c2abe539 | 2026-09-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Topco Associates, LLC | ed576bf1-3949-423e-af2e-e4b1a3839b21 | 2026-09-04 | Warnings | M012 |
| tussin nighttime cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 80d51af8-3a7b-4d22-8d4f-df5f91913047 | 2026-09-04 | Warnings | M012 |
| NO MORE NOSEBLEED | OXYMETAZOLINE HYDROCHLORIDE | DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. | 69d3f1fe-b476-4f84-8c5e-94957b74b46c | 2026-09-04 | Warnings | M012 |
| Ultra Fine Mist Sinus Relief | OXYMETAZOLINE HYDROCHLORIDE | DOLGENCORP, INC. | 5f134840-2465-4585-a85d-08d746f76f7a | 2026-09-03 | Warnings | M012 |
| Daytime Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE | Family Dollar (FAMILY WELLNESS) | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 2026-09-03 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 9a164cfc-b623-9a9f-e053-2a95a90a0173 | 4 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 9a164cfc-b623-9a9f-e053-2a95a90a0173 | 4 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 9a164cfc-b623-9a9f-e053-2a95a90a0173 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69729-782-10 | 69729078210 | 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-782-10) | 2019-02-18 | 0000-00-00 | No | No | Current |