Home NDC 0135-0578 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046781 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 178 · 3,551 matching rows.
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