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
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
250; 2; 10; 5 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

Additional Listing Data#

Finished product
Yes
Brand name base
Sanaflu Xtra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1193292

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-001-12Sanaflu Xtra12 in 1 BOXCAPSULE, GELATIN COATED1210

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
GELATININACTIVE INGREDIENT2G86QN327LADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NADULT FLU AND COUGH SANAFLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RADULT 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
NDCDashboard titleSPL versionValidationDashboard ZIP
48201-001SANAFLU XTRA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING, LLC]9Current NDC, Legacy NDC, 1 package rows20240124_4af8a566-5251-4d46-8692-87a3a0748334.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193292acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN4af8a566-5251-4d46-8692-87a3a074833410
1193292acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD4af8a566-5251-4d46-8692-87a3a074833410
1193292APAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY4af8a566-5251-4d46-8692-87a3a074833410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48201-001-124820100011212 CAPSULE, GELATIN COATED in 1 BOX (48201-001-12) 2015-04-300000-00-00NoNoCurrent