FDA.reportPublic FDA data

Banophen

Product NDC
0904-5307
11-digit product format
009045307
Labeler code
0904
Product ID
0904-5307_4b4333df-2739-654b-e063-6394a90a4a1d
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hcl
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-11-02
Marketing end
2028-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Banophen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477, 1020479

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
0904-5307-60Banophen100 in 1 BOTTLECAPSULE10010
0904-5307-80Banophen1000 in 1 BOTTLECAPSULE100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5307-60EA - Each0904-5307fbc100c3-1d2e-4360-bd2f-a92b1e556d3b12013-02-11
0904-5307-80EA - Each0904-5307602b6862-e0e7-4d9b-bcb4-48a7a3eba31612013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]4
DiphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]4
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]4
GelatinINACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]4
LactoseINACTIVE INGREDIENTJ2B2A4N98GDIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]4
Magnesium StearateINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]4
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]4
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MBANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2
GELATININACTIVE INGREDIENT2G86QN327LBANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GBANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MBANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHBANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LBANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GBANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5307BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 2 package rows20240214_7f2b72cc-d4f7-431f-be61-c103cf8c489e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020479BANOPHEN 50 MG Oral CapsulePSNd0f4b9f4-e727-4d47-b156-7bcdcb1606da106
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNd0f4b9f4-e727-4d47-b156-7bcdcb1606da106
1020479diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]SBDd0f4b9f4-e727-4d47-b156-7bcdcb1606da106
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDd0f4b9f4-e727-4d47-b156-7bcdcb1606da106
1020479Banophen 50 MG Oral CapsuleSYd0f4b9f4-e727-4d47-b156-7bcdcb1606da106
1020477diphenhydramine HCl 50 MG Oral CapsuleSYd0f4b9f4-e727-4d47-b156-7bcdcb1606da106
1020479BANOPHEN 50 MG Oral CapsulePSN20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020479diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]SBD20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020479Banophen 50 MG Oral CapsuleSY20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020477diphenhydramine HCl 50 MG Oral CapsuleSY20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020479BANOPHEN 50 MG Oral CapsulePSN7f2b72cc-d4f7-431f-be61-c103cf8c489e10
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN7f2b72cc-d4f7-431f-be61-c103cf8c489e10
1020479diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]SBD7f2b72cc-d4f7-431f-be61-c103cf8c489e10
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD7f2b72cc-d4f7-431f-be61-c103cf8c489e10
1020479Banophen 50 MG Oral CapsuleSY7f2b72cc-d4f7-431f-be61-c103cf8c489e10
1020477diphenhydramine HCl 50 MG Oral CapsuleSY7f2b72cc-d4f7-431f-be61-c103cf8c489e10
1020479BANOPHEN 50 MG Oral CapsulePSN0e06dca9-485a-4367-bcfa-07e0cc27c1287
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN0e06dca9-485a-4367-bcfa-07e0cc27c1287
1020479diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]SBD0e06dca9-485a-4367-bcfa-07e0cc27c1287
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD0e06dca9-485a-4367-bcfa-07e0cc27c1287
1020479Banophen 50 MG Oral CapsuleSY0e06dca9-485a-4367-bcfa-07e0cc27c1287
1020477diphenhydramine HCl 50 MG Oral CapsuleSY0e06dca9-485a-4367-bcfa-07e0cc27c1287
1020479BANOPHEN 50 MG Oral CapsulePSN0f52270a-b11a-4fa1-aac2-9fe5ff6254195
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN0f52270a-b11a-4fa1-aac2-9fe5ff6254195
1020479diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]SBD0f52270a-b11a-4fa1-aac2-9fe5ff6254195
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD0f52270a-b11a-4fa1-aac2-9fe5ff6254195
1020479Banophen 50 MG Oral CapsuleSY0f52270a-b11a-4fa1-aac2-9fe5ff6254195
1020477diphenhydramine HCl 50 MG Oral CapsuleSY0f52270a-b11a-4fa1-aac2-9fe5ff6254195
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNea0c7005-3122-4ff4-8bc1-dda8116803c14
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDea0c7005-3122-4ff4-8bc1-dda8116803c14
1020477diphenhydramine HCl 50 MG Oral CapsuleSYea0c7005-3122-4ff4-8bc1-dda8116803c14
1020479BANOPHEN 50 MG Oral CapsulePSNd4ec6dfd-61b0-7153-e053-2995a90ad88f2
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNd4ec6dfd-61b0-7153-e053-2995a90ad88f2
1020479diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]SBDd4ec6dfd-61b0-7153-e053-2995a90ad88f2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDd4ec6dfd-61b0-7153-e053-2995a90ad88f2
1020479Banophen 50 MG Oral CapsuleSYd4ec6dfd-61b0-7153-e053-2995a90ad88f2
1020477diphenhydramine HCl 50 MG Oral CapsuleSYd4ec6dfd-61b0-7153-e053-2995a90ad88f2
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1d026ead-c3de-4dc6-9d3c-5a603f6dde4e1
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1d026ead-c3de-4dc6-9d3c-5a603f6dde4e1
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1e01f8b8-ca29-902e-e063-6394a90a4cb81
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1d026ead-c3de-4dc6-9d3c-5a603f6dde4e1
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1d026ead-c3de-4dc6-9d3c-5a603f6dde4e1
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1e01f8b8-ca29-902e-e063-6394a90a4cb81
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1d026ead-c3de-4dc6-9d3c-5a603f6dde4e1
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1e01f8b8-ca29-902e-e063-6394a90a4cb81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5307-6000904530760100 CAPSULE in 1 BOTTLE (0904-5307-60) 100 capsule2009-11-022028-01-31NoNoCurrent
0904-5307-80009045307801000 CAPSULE in 1 BOTTLE (0904-5307-80) 1000 capsule2009-11-022028-01-31NoNoCurrent