Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
- Product NDC
- 69729-782
- 11-digit product format
- 697290782
- Labeler code
- 69729
- Product ID
- 69729-782_18adbc15-b127-cc7e-e063-6394a90a1e9c
- 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; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1656815 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 69729-782-10 | 2024-05-19 | C162847 | 48780-1 | d6a99b39-96b2-a426-e053-dadaa90af4c2 | Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) |
| 69729-782-10 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-96b2-a426-e053-dadaa90af4c2 | Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) |
| 69729-782-10 | 2022-04-12 | C162847 | 48780-1 | d6a99b39-96b2-a426-e053-dadaa90af4c2 | Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) |
| 69729-782-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-96b2-a426-e053-dadaa90af4c2 | Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69729-782 | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED [OPMX LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240521_9a164cfc-b623-9a9f-e053-2a95a90a0173.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 |