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 4 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gencare-Aspirin Low Dose Pain reliever (NSAID) ASPIRIN Pioneer Life Sciences, LLC 24d4f46a-c7a5-4e94-804f-1e307d8e8cfc 2026-08-09 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN DOLGENCORP, LLC b4064039-2345-4227-b83d-54dc13a838d3 2026-08-07 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN United Natural Foods, Inc. dba UNFI 87def9e0-0246-42cf-b8ea-2513d52e9f68 2026-08-07 Warnings Exact identifier application number: M013 berkley and jensen acetaminophen ACETAMINOPHEN BJWC dee57d73-73ac-48bb-b1da-9971f1ff21c4 2026-08-07 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Salado Sales, Inc. aef30709-f33d-48ff-b2d4-0639ffbd1ffd 2026-08-07 Warnings Exact identifier application number: M013 Aspirin ASPIRIN P & L Development, LLC 4cd74cec-a209-4e92-b853-fbe5c95f7678 2026-08-06 Warnings Exact identifier application number: M013 Tension Headache Aspirin-Free ACETAMINOPHEN, CAFFEINE Rite Aid Corporation 093a7c26-f2b1-4416-b193-81133d247d2e 2026-08-06 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bc17b2e5-4828-6a2e-e053-2995a90a8c63 2026-08-05 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC 997b9551-c222-4a9c-8ba1-09a5f97495fa 2026-08-05 Warnings Exact identifier application number: M013 Mantra Pain Gel raspberry ACETAMINOPHEN MOREMED INC. 7c8bdf49-a6d2-4e42-b006-375f103fd0ac 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER d2d2846d-4e0b-4d42-b300-60dd3b2cca1b 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER 960f5676-d8c5-470b-a663-4b8d152339b4 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER a60f6439-2033-4bd2-b78c-6c083414a12b 2026-08-05 Warnings Exact identifier application number: M013 pain relief PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE HARRIS TEETER 0afb6181-d0b1-4845-8230-faabf1b997dc 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Harris Teeter 8a3e3439-90ae-4fc9-8ff2-44b8363fa338 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Harris Teeter 50e7b939-e0eb-44ea-82ea-034e844e2c29 2026-08-05 Warnings Exact identifier application number: M013 pain relief aspirin Low Dose ASPIRIN Rite Aid Corporation df7835c9-f10f-40c6-8955-61423d94b677 2026-08-05 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN DOLGENCORP, LLC 7396c97e-8a51-4a21-8208-f13258b5285c 2026-08-05 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN Rite Aid Corporation 3b5d4a5a-8c65-4db1-bf01-e8df6523f45a 2026-08-04 Warnings Exact identifier application number: M013 childrens acetaminophen ACETAMINOPHEN WinCo Foods, LLC 4749a843-9c93-4edd-9b5f-a1e32666544e 2026-08-04 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