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 |
|---|---|---|---|---|---|---|
| Childrens Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 2026-05-27 | Warnings | M012 |
| Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 9aca1a68-893c-4770-8a48-d5d678058253 | 2026-05-27 | Warnings | M012 |
| Childrens Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | d26b5143-aa07-4114-a6ba-4f503aadd46f | 2026-05-27 | Warnings | M012 |
| Goodmeds Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | 37533188-8c91-428b-a796-c5afd9e4959f | 2026-05-27 | Warnings | M012 |
| Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 8252cdec-b668-4450-b045-e093479ab542 | 2026-05-27 | Warnings | M012 |
| Delsym Nighttime Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27f9d2db-38ce-41d2-8f1a-0eb171600274 | 2026-05-27 | Warnings | M012 |
| Delsym Cough Plus Sore Throat | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | b37b786e-0cce-419d-94ed-3b64a1eb1201 | 2026-05-27 | Warnings | M012 |
| Delsym Cough | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | a43d59f9-3a6c-4a7c-b98d-b86d6035f716 | 2026-05-27 | Warnings | M012 |
| Cold and Flu Relief Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 5700ef26-ffa6-480a-bf36-bd5111799e9b | 2026-05-27 | Warnings | M012 |
| Air Power | GUAIFENESIN | Schwabe North America, Inc | 5cdefc7a-6242-4681-88a3-04422a1d48d3 | 2026-05-27 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALMART INC. | adb658c8-db8d-4db6-80c8-e0f2de88a2de | 2026-05-27 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | c71427d4-707f-411f-8bd4-133517a9992b | 2026-05-26 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | CVS PHARMACY, INC | 643e929d-9e62-4260-91ee-e88a184dd7cd | 2026-05-26 | Warnings | M012 |
| TopCare Day Time Nite Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | c00ff684-acaf-4fbe-bc74-7e48751b927d | 2026-05-26 | Warnings | M012 |
| Goodmeds Non-Drowsy Nasal Decongestant PE | PHENYLEPHRINE | Cabinet Health P.B.C. | 4e75da23-35f2-431c-92cb-c2c4cb3f09f1 | 2026-05-26 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS Pharmacy | 13492631-d5de-4562-a201-664f7d3591de | 2026-05-26 | Warnings | M012 |
| Sinufrin Decongestant | NASAL CONGESTION RELIEF | NeilMed Pharmaceuticals Inc | 52a2e5f9-e0a2-02f7-e063-6294a90a3ae9 | 2026-05-25 | Warnings | M012 |
| Cough Suppressant Adult | DEXTROMETHORPHAN HYDROBROMIDE | Rugby Laboratories | 47b713bd-4c1e-f44a-e063-6294a90a63d3 | 2026-05-25 | Warnings | M012 |
| ClorRelief | CHLORPHENIRAMINE MALEATE | FERRER MEDICAL INNOVATIONS LLC | db729011-f72f-5911-e053-2a95a90a68bf | 2026-05-22 | Warnings | M012 |
| Childrens Dye Free Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | 74ff4f0d-7952-4b74-b1b2-5a2beab91f7c | 2026-05-22 | 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 |