Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
- Product NDC
- 69729-122
- 11-digit product format
- 697290122
- Labeler code
- 69729
- Product ID
- 69729-122_2860515b-46f8-6018-e063-6294a90af085
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-08-26
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 500; 4; 10 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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, Chlorpheniramine Maleate, Phenylephrine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| CHLORPHENIRAMINE MALEATE | 4 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ |
| Rxcui | 2463332 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 69729-122-27 | 2022-10-31 | C162847 | 48780-1 | d6a99b39-ff54-a426-e053-dadaa90af4c2 | Coldtac Ultra tabs (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) |
| 69729-122-37 | 2022-10-31 | C162847 | 48780-1 | d6a99b39-ff54-a426-e053-dadaa90af4c2 | Coldtac Ultra tabs (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) |
| 69729-122-38 | 2022-10-31 | C162847 | 48780-1 | d6a99b39-ff54-a426-e053-dadaa90af4c2 | Coldtac Ultra tabs (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) |
| 69729-122-27 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ff54-a426-e053-dadaa90af4c2 | Coldtac Ultra tabs (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) |
| 69729-122-37 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ff54-a426-e053-dadaa90af4c2 | Coldtac Ultra tabs (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) |
| 69729-122-38 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ff54-a426-e053-dadaa90af4c2 | Coldtac Ultra tabs (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69729-122-06 | Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | 2 in 1 PACKET | TABLET | 2 | | 4 |
| 69729-122-06 | Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | 3 in 1 CARTON | TABLET | 3 | | 4 |
| 69729-122-27 | Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | 2 in 1 POUCH | TABLET | 2 | | 4 |
| 69729-122-37 | Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | 12 in 1 POUCH | TABLET | 12 | | 4 |
| 69729-122-38 | Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | 144 in 1 POUCH | TABLET | 144 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69729-122 | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL TABLET [OPMX LLC] | 4 | Current NDC, Legacy NDC, 5 package rows | 20241206_b373a3a8-68c4-0187-e053-2995a90aad62.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69729-122-06 | 69729012206 | 3 PACKET in 1 CARTON (69729-122-06) / 2 TABLET in 1 PACKET | 3 packet | 2023-09-04 | | No | No | Historical |
| 69729-122-27 | 69729012227 | 2 TABLET in 1 POUCH (69729-122-27) | 2 tablet | 2019-08-26 | 0000-00-00 | No | No | Current |
| 69729-122-37 | 69729012237 | 12 TABLET in 1 POUCH (69729-122-37) | 12 tablet | 2019-08-26 | 0000-00-00 | No | No | Current |
| 69729-122-38 | 69729012238 | 144 TABLET in 1 POUCH (69729-122-38) | 144 tablet | 2019-08-26 | 0000-00-00 | No | No | Current |