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 3 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Headache Formula Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE ARMY AND AIR FORCE EXCHANGE SERVICE ee8d0961-7572-471f-8c96-b4c0bd354de2 2026-08-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Rugby Laboratories 76f10ee2-1d6a-097c-e053-2991aa0af526 2026-08-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Major Pharmaceuticals 780aad35-d0f1-44b1-e053-2991aa0af9a7 2026-08-18 Warnings Exact identifier application number: M013 CHILDRENS PAIN AND FEVER ACETAMINOPHEN Amazon.com Services LLC 5eacbc4f-d20a-4c22-9680-4a648e24de43 2026-08-18 Warnings Exact identifier application number: M013 Pain Relief Childrens ACETAMINOPHEN WinCo Foods, LLC 15921c3f-e8d4-4794-983f-63bb926f6f86 2026-08-15 Warnings Exact identifier application number: M013 Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY e4cbfb06-d826-4d08-95d6-60305c417625 2026-08-14 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN CVS Pharmacy,Inc. 3738d35c-1e83-40df-9292-c54e6b2c8353 2026-08-14 Warnings Exact identifier application number: M013 CVS Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY 22a48a33-995b-481e-9e4e-1ad7ec346f44 2026-08-14 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN AND CAFFEINE CVS Pharmacy 31ccc867-ca83-70a9-f3d5-5644030047b8 2026-08-13 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Topco Associates, LLC 8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101 2026-08-12 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN HARRIS TEETER 54e69d5a-55d7-4ebe-8494-0be93613f1e2 2026-08-12 Warnings Exact identifier application number: M013 Chewable Aspirin ASPIRIN HARRIS TEETER c6a28c83-60c9-3304-e053-2a95a90aa06c 2026-08-12 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN HARRIS TEETER 93cbd3cb-1072-89e6-e053-2995a90a2f15 2026-08-12 Warnings Exact identifier application number: M013 Adult Chewable Aspirin ASPIRIN HARRIS TEETER c6a28617-1769-7a7d-e053-2995a90a1ea0 2026-08-12 Warnings Exact identifier application number: M013 Gencare- Pain Relief Acetaminophen ACETAMINOPHEN Pioneer Life Sciences, LLC 2111c91b-2fd7-4ab3-946a-d4e0cf46399a 2026-08-12 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN Salado Sales, Inc. 1dbd8480-5cb4-4577-9091-b2a2add4f1af 2026-08-12 Warnings Exact identifier application number: M013 pain relief childrens ACETAMINOPHEN Rite Aid Corporation 29ecdd2d-aeaf-40a8-a347-011088009ea6 2026-08-11 Warnings Exact identifier application number: M013 Fast Acting Pedia Crae ACETAMINOPHEN Randob Labs., Ltd. e069060f-fbb2-4c7a-b872-00b3ab86d01b 2026-08-11 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN Amazon.com Services LLC c7cc0681-4c0b-4565-99df-d0168c8ba1ba 2026-08-10 Warnings Exact identifier application number: M013 GenCare Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Pioneer Life Sciences, LLC ac8c4bdf-30c9-2b09-e053-2a95a90a9b67 2026-08-09 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