FDA.reportPublic FDA data

Banophen

Product NDC
0904-5551
11-digit product format
009045551
Labeler code
0904
Product ID
0904-5551_e0443532-ae16-498a-86f5-c706edb11aa6
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630, 1092421

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

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