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 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
application number: M012
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e2026-08-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
application number: M012
Tussin DM Daytime NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd59f6c64-8311-48ba-90d1-8000b04bfcda2026-08-13WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHTACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC1c5578e6-7e67-c467-e063-6294a90a6e0b2026-08-12WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLCf95220c5-e55c-4271-a267-d004ad2447bf2026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.569b8efa-8458-49f7-a665-6b7016a105052026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY DYE FREE Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.e6671e8b-653a-4f4e-b6f3-e31fcd14fbd72026-08-12WarningsExact 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