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 |
|---|---|---|---|---|---|---|
| Medi-First Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 9654f5cd-74d7-44a2-9674-666d1e94ffa7 | 2025-09-08 | Warnings | M012 |
| Otis Clapp Mygrex | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | f196f2c5-a100-42b1-bd01-0327b223838e | 2025-09-08 | Warnings | M012 |
| Medique Diphen | DIPHENHYDRAMINE HYDROCHLORIDE | Unifirst First Aid Corporation | b61ee2e0-2543-447d-9fc4-23363d46ce04 | 2025-09-08 | Warnings | M012 |
| Green Guard Allergy 2 Relief | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 16fddca9-a66b-41e6-9423-eaf091d3971e | 2025-09-08 | Warnings | M012 |
| Medique Medi-Phenyl | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | d7d62ac1-1333-4366-884b-26537766ce38 | 2025-09-08 | Warnings | M012 |
| Unishield Sinus Decongestant | PHENYLEPHRINE HCL | Unishield | b8f68d9d-2d38-414a-e053-2a95a90a15ec | 2025-09-08 | Warnings | M012 |
| McKesson Sinus Pain and Pressure Relief | ACETAMINOPHEN, PHENYLEPHRINE HCL | McKesson Medical-Surgical | e0cbb213-4f4f-4045-e053-2a95a90a2a18 | 2025-09-08 | Warnings | M012 |
| Medique Medicidin D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 1f172d58-4050-424b-9743-130d8e618fe8 | 2025-09-08 | Warnings | M012 |
| Medique Cold Cough Product | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , | Unifirst First Aid Corporation | e8059137-efba-398c-e053-2a95a90a21f2 | 2025-09-08 | Warnings | M012 |
| Medique Medi-Mucus | DEXTROMETHORPHAN HBR, GUAIFENESIN | Unifirst First Aid Corporation | f3bb862a-9cb8-f644-e053-2a95a90a5f4f | 2025-09-08 | Warnings | M012 |
| Physicians Care Cough and Sore Throat | MENTHOL | Acme United Corporation | 4e02223d-f34b-333e-e054-00144ff8d46c | 2025-09-08 | Warnings | M012 |
| Physicians Care Non-Drowsy Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Acme United | 186ec543-1f23-75d6-e063-6294a90a46b9 | 2025-09-08 | Warnings | M012 |
| PhysiciansCare Sinus Non-Drowsy | PHENYLEPHRINE HCL | Acme United Corporation | a6daf3ef-f386-4de4-b38e-d0b90c9ae62b | 2025-09-08 | Warnings | M012 |
| PhysiciansCare Allergy Multi-Symptom Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Acme United Corporation | fd101c27-6ba9-4cd3-baec-a354504c37a0 | 2025-09-08 | Warnings | M012 |
| Green Guard Honey Lemon Cough Drop | MENTHOL 8.6 MG | Unifirst First Aid Corporation | 8a94f090-61d6-4909-e053-2995a90aee38 | 2025-09-08 | Warnings | M012 |
| Green Guard Cough Drop Relief | MENTHOL | Unifirst First Aid Corporation | 0fc4cb11-8ff9-4eff-9588-c73eef4e0137 | 2025-09-08 | Warnings | M012 |
| Multi-Symptom Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, , | Unifirst First Aid Corporation | e6ea6faf-baff-a130-e053-2a95a90a085a | 2025-09-08 | Warnings | M012 |
| MEDIQUE Medikoff Drops | MENTHOL | Unifirst First Aid Corporation | 0d6b4443-16a1-4851-bb03-d7407167551d | 2025-09-08 | Warnings | M012 |
| Medique Sugar Free Medikoff Drops | MENTHOL | Unifirst First Aid Corporation | 92d13e19-4e7b-4565-970e-504abf02579a | 2025-09-08 | Warnings | M012 |
| Medique at Home Diphen | DIPHENHYDRAMINE HCL | Unifirst First Aid Corporation | b56d1966-efd7-56eb-e053-2995a90a89b5 | 2025-09-08 | 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 |