FDA.reportPublic FDA data

Banophen

Product NDC
63629-9451
11-digit product format
636299451
Labeler code
63629
Product ID
63629-9451_5b78dcf7-ed29-4ab7-a0fe-7cdad0b16041
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

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 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
63629-9451-1Banophen30 in 1 BOTTLECAPSULE30106
63629-9451-2Banophen60 in 1 BOTTLECAPSULE60106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9451BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 2 package rows20240511_d0f4b9f4-e727-4d47-b156-7bcdcb1606da.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 128 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINFamily Dollar Services Inc8aee8108-a4e0-4956-8e37-6b3b1c5dc6832024-12-18WarningsExact identifier
application number: M012
TopCare Chest Congestion ReliefGUAIFENESINTOPCO ASSOCIATES LLCb8339617-17ce-4ad7-af38-399ecc74d8642024-12-18WarningsExact identifier
application number: M012
Kroger Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETHE KROGER CO976bfdcf-2110-486c-aa6e-cd2067334cdc2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINAmerisourceBergen Drug Corp79cefd46-bd19-4a1d-9cb1-e85ff0f124942024-12-18WarningsExact identifier
application number: M012
Leader Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCardinal Health8397e1b9-e83e-4c6a-b858-1663c23658402024-12-18WarningsExact identifier
application number: M012
GNP Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEAmerisourceBergen Drug Corp63932e68-b09d-4500-bc1d-cfb2c267df1c2024-12-18WarningsExact identifier
application number: M012
Meijer Chest Congestion ReliefGUAIFENESINMeijer Distribution Inc.ae02e0bd-d9e7-495f-b01f-b135b96934a02024-12-18WarningsExact identifier
application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PEGUAIFENESIN/PHENYLEPHRINETOPCO ASSOCIATES LLCb6c0362f-86ca-4f08-ba53-800c6df2c0252024-12-18WarningsExact identifier
application number: M012
Sunmark Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC10cad9a7-1223-470c-9027-807891217d402024-12-18WarningsExact identifier
application number: M012
Kroger Mucus ReliefGUAIFENESINTHE KROGER CO2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e2024-12-18WarningsExact identifier
application number: M012
Quality Choice Mucus ReliefGUAIFENESINChain Drug Marketing Association41f88b43-3e0a-4650-b167-a72afe6177e82024-12-18WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRugby Laboratories5da36516-9f94-49cb-9421-0c310abcd1162024-12-18WarningsExact identifier
application number: M012
Kroger Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTHE KROGER CO430c6604-93a7-4df6-a657-ba438aa614252024-12-18WarningsExact identifier
application number: M012
Discount Drugmart Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart, Inc1ac281e1-22ea-42f8-98fe-ab3d5ff9a2082024-12-18WarningsExact identifier
application number: M012
TopCare Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC4c50233e-1dcb-427d-ba63-1538cf3700612024-12-18WarningsExact identifier
application number: M012
Dollar General Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINDolgencorp, LLC718f08d2-3757-4f3e-915e-3e4982ad090f2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmerisourceBergen Drug Corpe4610d53-4459-43a0-9351-f0ac8586df602024-12-18WarningsExact identifier
application number: M012
Always Save Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEValu Merch5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f62024-12-17WarningsExact identifier
application number: M012
ChestrubCAMPHOR MENTHOL EUCALYPTUS OILDelta Brands Inc8e6f731f-c16a-41b2-9786-0cab588cfc8e2024-12-17WarningsExact identifier
application number: M012
Mentholatum Nighttime Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company5539ae74-9723-480d-b35f-0a6644bf54ad2024-12-17WarningsExact identifier
application number: M012

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9451-16362994510130 CAPSULE in 1 BOTTLE (63629-9451-1) 30 capsule2022-09-262028-01-31NoNoCurrent
63629-9451-26362994510260 CAPSULE in 1 BOTTLE (63629-9451-2) 60 capsule2022-09-262028-01-31NoNoCurrent