COLTALIN-ND
- Product NDC
- 51467-013
- 11-digit product format
- 514670013
- Labeler code
- 51467
- Product ID
- 51467-013_4abf20fb-7d7c-4af9-e063-6294a90ad924
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Phenylephrine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- FORTUNE PHARMACAL COMPANY LIMITED
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-30
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COLTALIN-ND
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 04JA59TNSJ |
| Rxcui | 1046378 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51467-013-01 | COLTALIN-ND | 12 in 1 BLISTER PACK | TABLET | 12 | | 3 |
| 51467-013-01 | COLTALIN-ND | 2 in 1 BOX | TABLET | 2 | | 3 |
| 51467-013-02 | COLTALIN-ND | 3 in 1 BOX | TABLET | 3 | | 3 |
| 51467-013-02 | COLTALIN-ND | 12 in 1 BLISTER PACK | TABLET | 12 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51467-013 | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | Current NDC, 4 package rows | 20241228_7373ad43-0afa-4d21-8afc-a737e9f19290.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51467-013-01 | 51467001301 | 2 BLISTER PACK in 1 BOX (51467-013-01) / 12 TABLET in 1 BLISTER PACK | 2 blister pack | 2026-01-30 | No | No | Historical |
| 51467-013-02 | 51467001302 | 3 BLISTER PACK in 1 BOX (51467-013-02) / 12 TABLET in 1 BLISTER PACK | 3 blister pack | 2026-01-30 | No | No | Historical |