COLTALIN-ND
- Product NDC
- 51467-008
- 11-digit product format
- 514670008
- Labeler code
- 51467
- Product ID
- 51467-008_43811fe7-01d2-6dae-e063-6394a90a24fc
- 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
- 2004-03-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COLTALIN-ND
- Listing expiration
- 2026-12-31
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 |
|---|
| 51467-008-01 | COLTALIN-ND | 2 in 1 BOX | TABLET | 2 | | 6 |
| 51467-008-01 | COLTALIN-ND | 12 in 1 BLISTER PACK | TABLET | 12 | | 6 |
| 51467-008-02 | COLTALIN-ND | 12 in 1 BLISTER PACK | TABLET | 12 | | 6 |
| 51467-008-02 | COLTALIN-ND | 3 in 1 BOX | TABLET | 3 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51467-008 | COLTALIN-ND (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241121_28f41696-7d67-436e-aa33-86d8ba82efd7.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 |
|---|
| 51467-008-01 | 51467000801 | 2 BLISTER PACK in 1 BOX (51467-008-01) / 12 TABLET in 1 BLISTER PACK | 2 blister pack | 2004-03-01 | 0000-00-00 | No | No | Current |
| 51467-008-02 | 51467000802 | 3 BLISTER PACK in 1 BOX (51467-008-02) / 12 TABLET in 1 BLISTER PACK | 3 blister pack | 2016-04-26 | 0000-00-00 | No | No | Current |