FDA.reportPublic FDA data

Banophen

Product NDC
0904-5551
11-digit product format
009045551
Labeler code
0904
Product ID
0904-5551_4eb3f9e3-fdb3-4298-b855-c4c9165cf1d8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-02
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Banophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5551-24Banophen12 in 1 BLISTER PACKTABLET, FILM COATED1216
0904-5551-24Banophen2 in 1 CARTONTABLET, FILM COATED216
0904-5551-59Banophen1 in 1 CARTONTABLET, FILM COATED116
0904-5551-59Banophen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5551-24EA - Each0904-5551805dcd85-34b6-4a0a-9406-d46680925db812012-07-24
0904-5551-59EA - Each0904-55516037c229-d392-48f1-bbd8-febe968f67a312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]4
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5551BANOPHEN (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]15Current NDC, Legacy NDC, 4 package rows20241103_69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1.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 85 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLWALGREENS CO.bfc58cd5-9815-43af-895d-ec6cbd10937e2025-11-26WarningsExact identifier
application number: M012
Walgreen Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY40c038a3-91c7-4ed0-8210-65d58b82ca2b2025-11-26WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWALGREENS CO724554ab-60b8-46c8-96a8-a98242604e3b2025-11-26WarningsExact identifier
application number: M012
Walgreens Grape FlavorCHILDREN COUGH AND CHEST CONGESTIONWALGREENS795cf1af-3847-46bc-b605-64a38e57cca22025-11-26WarningsExact identifier
application number: M012
WalgreensCHILDRENS STUFFY NOSE AND COLDWALGREENS CO.7ac3de2d-1d10-49ec-a2da-da46977684ad2025-11-26WarningsExact identifier
application number: M012
Childrens Chest Congestion ReliefGUAIFENESINWALGREENS COMPANYc1382512-e6f3-4bdf-a9e6-4f68dd5ea5532025-11-26WarningsExact identifier
application number: M012
Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.96948973-09e3-4c05-8982-0494ebeaac4b2025-11-26WarningsExact identifier
application number: M012
WALGREEN ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY02ad9f98-07ad-4786-a1ab-169b870fec012025-11-26WarningsExact identifier
application number: M012
Walgreen CherryGUAIFENESINWALGREEN COMPANY1f1cb4a5-1ebd-483c-bf82-16931da00e052025-11-26WarningsExact identifier
application number: M012
Walgreen Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.801880b2-6116-4d26-a7bf-a669eef6ad8b2025-11-26WarningsExact identifier
application number: M012
Walgreen Daytimel Kids Cold Cough plus MucusGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.452159e0-1204-460c-981f-cace4e815c6f2025-11-26WarningsExact identifier
application number: M012
Multi Symptom Wal Flu Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWALGREEN CO.9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb2025-11-25WarningsExact identifier
application number: M012
WALGREEN Daytime Multi Symptom Flu Relief Max StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBRWALGREENS CO.c92a0f47-0b7c-4034-83d1-b7d2ed8022fc2025-11-25WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREENS CO.428081f5-b7eb-42da-963c-a587a44b2a792025-11-25WarningsExact identifier
application number: M012
Walgreen NightTime Cold and Flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWALGREENS CO.6b3766e6-d0d4-49e0-90da-fc893aef33292025-11-25WarningsExact identifier
application number: M012
Adult Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANY586310f3-0014-4cfc-9d86-961b3fb7aa8c2025-11-25WarningsExact identifier
application number: M012
childrens Allergy Dye Free Wal DrylDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.4e64e040-1662-4dc9-b33f-3e119e0b3f7b2025-11-25WarningsExact identifier
application number: M012
WalgreenNASALWALGREENS COd38f8406-d7b9-472c-a472-58968bbdb9932025-11-25WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC780907b8-34ba-4ec8-bcdf-b2a31bd111df2025-11-25WarningsExact identifier
application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCd13efbcd-1277-45d0-8389-1ba0337f7a242025-11-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092421BANOPHEN 25 MG Oral TabletPSN69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c116
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c116
1092421diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]SBD69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c116
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c116
1092421Banophen 25 MG Oral TabletSY69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c116
1092421BANOPHEN 25 MG Oral TabletPSNe1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd5
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNe1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd5
1092421diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]SBDe1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDe1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd5
1092421Banophen 25 MG Oral TabletSYe1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd5
1092421BANOPHEN 25 MG Oral TabletPSN62934d0f-b23d-4c03-9d60-a7bad41f9b423
1092421BANOPHEN 25 MG Oral TabletPSNcb498f07-75fe-47d5-9620-f87405d168af3
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN62934d0f-b23d-4c03-9d60-a7bad41f9b423
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNcb498f07-75fe-47d5-9620-f87405d168af3
1092421diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]SBD62934d0f-b23d-4c03-9d60-a7bad41f9b423
1092421diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]SBDcb498f07-75fe-47d5-9620-f87405d168af3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD62934d0f-b23d-4c03-9d60-a7bad41f9b423
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDcb498f07-75fe-47d5-9620-f87405d168af3
1092421Banophen 25 MG Oral TabletSY62934d0f-b23d-4c03-9d60-a7bad41f9b423
1092421Banophen 25 MG Oral TabletSYcb498f07-75fe-47d5-9620-f87405d168af3
1092421BANOPHEN 25 MG Oral TabletPSN2cdbe7df-4c67-9b05-e063-6394a90a46991
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2cdbe7df-4c67-9b05-e063-6394a90a46991
1092421diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]SBD2cdbe7df-4c67-9b05-e063-6394a90a46991
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2cdbe7df-4c67-9b05-e063-6394a90a46991
1092421Banophen 25 MG Oral TabletSY2cdbe7df-4c67-9b05-e063-6394a90a46991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5551-24009045551242 BLISTER PACK in 1 CARTON (0904-5551-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1990-03-020000-00-00NoNoCurrent
0904-5551-59009045551591 BOTTLE, PLASTIC in 1 CARTON (0904-5551-59) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1990-03-020000-00-00NoNoCurrent