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 AND FLU DAYTIME SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORP | 9de99931-31ef-79e2-e053-2a95a90a98ad | 2024-12-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | TopCo Associates LLC | 3ef6d155-b95b-4b30-87a8-8ed811b1520f | 2024-12-03 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | a1b2b16d-c767-2945-e053-2995a90a4834 | 2024-12-03 | Warnings | M012 |
| Sinus Congestion and Pain Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TopCare | fa9b2748-0474-4a39-a2b8-bb6f0678c1d1 | 2024-12-03 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | a9640e09-369c-3c55-e053-2a95a90aebd5 | 2024-12-03 | Warnings | M012 |
| Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | ec7e5e2e-23c7-32ae-e053-2995a90a1251 | 2024-12-03 | Warnings | M012 |
| COLD AND FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | cbb179c8-31fb-4a3a-9f23-4024350f8b7f | 2024-12-03 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | a96431a0-b05d-4812-e053-2a95a90a5af6 | 2024-12-03 | Warnings | M012 |
| Cold Max Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | TopCo Associates LLC | aa0d6762-b803-4630-8f74-780b7ea9acff | 2024-12-03 | Warnings | M012 |
| Cold plus Head Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | ec7e5e2e-23c5-32ae-e053-2995a90a1251 | 2024-12-03 | Warnings | M012 |
| Cold Plus Head Congestion Day and Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | TopCo Associates LLC | 898eb1c7-395a-4845-9d0a-719fc78d86b7 | 2024-12-03 | Warnings | M012 |
| Cold Plus Head Congestion Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | TopCo Associates LLC | 7854c1fd-b5fc-477d-a79e-ff006ebf6fe5 | 2024-12-03 | Warnings | M012 |
| Cold and Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TopCo Associates LLC | e07d880b-a12a-4e5e-94c0-bd36bcfe738c | 2024-12-03 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | bd0a3679-1f7c-4c41-e053-2995a90a8fcb | 2024-12-03 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | bd09e4f3-3211-8c08-e053-2a95a90a73f9 | 2024-12-03 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b373a3a8-68c4-0187-e053-2995a90aad62 | 2024-12-03 | Warnings | M012 |
| Mucus Relief Cold and Flu All In One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | a1b281ec-fd42-963c-e053-2a95a90a4b71 | 2024-12-03 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | b3366ad4-5ef4-eb70-e053-2995a90acf33 | 2024-12-03 | Warnings | M012 |
| Meijer Medicated Chest Rub, 3.53 oz. Lavender | MENTHOL, CAMPHOR, EUCALYPTUS OIL | Meijer Distribution | 22516f25-b8aa-7511-e063-6394a90a6125 | 2024-12-03 | Warnings | M012 |
| Tenalif Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cd9513-1a42-e990-e063-6294a90a57df | 2024-12-03 | 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 |