FLONASE
- Product NDC
- 0135-0578
- 11-digit product format
- 001350578
- Labeler code
- 0135
- Product ID
- 0135-0578_1599c55d-8de5-cc14-e063-6394a90aba82
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, chlorpheniramine maleate, phenylephrine hcl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-03-10
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 2; 5 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
- FLONASE
- Brand name suffix
- Headache and Allergy Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ |
| Rxcui | 1046781 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-0578-01 | FLONASEHeadache and Allergy Relief | 12 in 1 BLISTER PACK | TABLET | 12 | | 4 |
| 0135-0578-01 | FLONASEHeadache and Allergy Relief | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 0135-0578-02 | FLONASEHeadache and Allergy Relief | 4 in 1 CARTON | TABLET | 4 | | 4 |
| 0135-0578-02 | FLONASEHeadache and Allergy Relief | 48 in 1 BLISTER PACK | TABLET | 48 | | 4 |
| 0135-0578-03 | FLONASEHeadache and Allergy Relief | 8 in 1 CARTON | TABLET | 8 | | 4 |
| 0135-0578-03 | FLONASEHeadache and Allergy Relief | 96 in 1 BLISTER PACK | TABLET | 96 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0578 | FLONASE HEADACHE AND ALLERGY RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [HALEON US HOLDINGS LLC] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240410_282c103c-3888-4a35-a5b1-d492ed6892c1.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 |
|---|
| 0135-0578-01 | 00135057801 | 1 BLISTER PACK in 1 CARTON (0135-0578-01) / 12 TABLET in 1 BLISTER PACK | 1 blister pack | 2022-03-10 | 0000-00-00 | No | No | Current |
| 0135-0578-02 | 00135057802 | 4 BLISTER PACK in 1 CARTON (0135-0578-02) / 48 TABLET in 1 BLISTER PACK | 4 blister pack | 2022-03-10 | 0000-00-00 | No | No | Current |
| 0135-0578-03 | 00135057803 | 8 BLISTER PACK in 1 CARTON (0135-0578-03) / 96 TABLET in 1 BLISTER PACK | 8 blister pack | 2022-03-10 | 0000-00-00 | No | No | Current |