FDA.reportPublic FDA data

Banophen

Product NDC
71335-0081
11-digit product format
713350081
Labeler code
71335
Product ID
71335-0081_6129c299-3b41-4276-a828-d074abb1669e
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hcl
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020477Internal RxNorm lookup
1020479Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
20f00537-2c8a-45d1-8e5f-ec276d0a47b6Available on FDA.report

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
71335-0081-0Banophen12 in 1 BOTTLECAPSULE1211
71335-0081-1Banophen15 in 1 BOTTLECAPSULE1511
71335-0081-2Banophen20 in 1 BOTTLECAPSULE2011
71335-0081-3Banophen30 in 1 BOTTLECAPSULE3011
71335-0081-4Banophen10 in 1 BOTTLECAPSULE1011
71335-0081-5Banophen6 in 1 BOTTLECAPSULE611
71335-0081-6Banophen100 in 1 BOTTLECAPSULE10011
71335-0081-7Banophen90 in 1 BOTTLECAPSULE9011
71335-0081-8Banophen60 in 1 BOTTLECAPSULE6011
71335-0081-9Banophen2 in 1 BOTTLECAPSULE211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0081-2EA - Each71335-00819eaa95ce-9f65-4f93-992a-47e4d3c5e79612022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0081BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20240510_20f00537-2c8a-45d1-8e5f-ec276d0a47b6.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 1 of 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0081-07133500810012 CAPSULE in 1 BOTTLE (71335-0081-0) 12 capsule2022-02-092028-01-31NoNoCurrent
71335-0081-17133500810115 CAPSULE in 1 BOTTLE (71335-0081-1) 15 capsule2020-05-182028-01-31NoNoCurrent
71335-0081-27133500810220 CAPSULE in 1 BOTTLE (71335-0081-2) 20 capsule2018-04-202028-01-31NoNoCurrent
71335-0081-37133500810330 CAPSULE in 1 BOTTLE (71335-0081-3) 30 capsule2018-08-152028-01-31NoNoCurrent
71335-0081-47133500810410 CAPSULE in 1 BOTTLE (71335-0081-4) 10 capsule2019-09-092028-01-31NoNoCurrent
71335-0081-5713350081056 CAPSULE in 1 BOTTLE (71335-0081-5) 6 capsule2019-08-072028-01-31NoNoCurrent
71335-0081-671335008106100 CAPSULE in 1 BOTTLE (71335-0081-6) 100 capsule2018-05-072028-01-31NoNoCurrent
71335-0081-77133500810790 CAPSULE in 1 BOTTLE (71335-0081-7) 90 capsule2022-02-092028-01-31NoNoCurrent
71335-0081-87133500810860 CAPSULE in 1 BOTTLE (71335-0081-8) 60 capsule2022-02-092028-01-31NoNoCurrent
71335-0081-9713350081092 CAPSULE in 1 BOTTLE (71335-0081-9) 2 capsule2022-02-092028-01-31NoNoCurrent