Home NDC 48201-001 Sanaflu Xtra
Product NDC 48201-001
11-digit product format 482010001
Labeler code 48201
Product ID 48201-001_42404180-fa1a-fcf6-e063-6394a90a281f
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler GRANDALL DISTRIBUTING, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-04-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active strength 10; 5; 250; 2 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 Sanaflu Xtra
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 ACETAMINOPHEN 250 mg/1 CHLORPHENIRAMINE MALEATE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1193292 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 48201-001-12 Sanaflu Xtra 12 in 1 BOX CAPSULE, GELATIN COATED 12 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 METHYLPARABEN SODIUM INACTIVE INGREDIENT CR6K9C2NHK ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 PROPYLPARABEN SODIUM INACTIVE INGREDIENT 625NNB0G9N ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 48201-001 SANAFLU XTRA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING, LLC] 9 Current NDC, Legacy NDC, 1 package rows 20240124_4af8a566-5251-4d46-8692-87a3a0748334.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 26 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc f818417e-0b31-4fe7-8313-4160a00b248a 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen ACETAMINOPHEN New World Imports, Inc c4f82ed8-b82c-47bb-9ab9-108a13d29cf7 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 5103450a-3095-49cc-9823-4fb4c1d258ff 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Non-Aspirin PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 499b2bf8-72fb-4500-b16e-517cab09a8ae 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 933154b9-c9d6-4260-8775-1c83631c74e4 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc c93aa5e4-3994-439f-8f14-4e81773ed4e2 2025-12-22 Warnings Exact identifier application number: M013 Acetaminophen Diphenhydramine HCl ACETAMINOPHEN DIPHENHYDRAMINE HCL Granules USA, Inc. 8c9f68e3-fedc-6457-e053-2995a90a045a 2025-12-22 Warnings Exact identifier application number: M013 Aspirin ASPIRIN L.N.K. International, Inc. 35005045-57b2-4ffe-ab70-22d570c1b161 2025-12-22 Warnings Exact identifier application number: M013 Tension Headache Relief ACETAMINOPHEN, CAFFEINE NUVICARE LLC ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Walmart 175495fd-c561-f813-e063-6294a90aac80 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALMART INC 21b22e9f-b6d1-1819-e063-6294a90ae09c 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine HCL ACETAMINOPHEN AND DIPHENHYDRAMINE HCL SAFEWAY f18c1aa2-5f8b-5458-e053-2995a90ab947 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Meijer 181b3148-fa33-c650-e063-6294a90a0de6 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN TOPCO ASSOCIATES LLC 1a00a49e-f9ff-b928-e063-6394a90a4cb5 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PUBLIX SUPERMARKETS, INC 08f57305-0c4b-96b1-e063-6394a90a77df 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine HCL ACETAMINOPHEN AND DIPHENHYDRAMINE HCL PUBLIX SUPERMARKETS, INC 08f549cf-042a-7bf2-e063-6394a90a83ef 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. b8a855ae-c0a3-0b05-e053-2a95a90ac8a8 2025-12-19 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Marc Glassman, Inc. f708e1ec-cf2a-4e2b-851f-f6b703f359b2 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. b375de90-25c7-aa55-e053-2995a90a3cf8 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN TARGET CORPORATION e64a3c32-5466-0662-e053-2a95a90ae963 2025-12-19 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 48201-001-12 48201000112 12 CAPSULE, GELATIN COATED in 1 BOX (48201-001-12) 2015-04-30 0000-00-00 No No Current