FDA.reportPublic FDA data

Banophen

Product NDC
68788-7830
11-digit product format
687887830
Labeler code
68788
Product ID
68788-7830_241c4be4-79e6-41e5-a2b3-2cd460d51088
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hcl
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
341
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-08
Marketing end
2028-01-30
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
0f52270a-b11a-4fa1-aac2-9fe5ff625419Available 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
68788-7830-1Banophen15 in 1 BOTTLECAPSULE155
68788-7830-3Banophen30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7830-1EA - Each68788-78303633ba5d-d90a-4b2b-ac83-a84ee8205b4812021-02-05
68788-7830-3EA - Each68788-78305657f422-ff83-4643-a8e2-2bd8449f7f2a12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7830BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20250331_0f52270a-b11a-4fa1-aac2-9fe5ff625419.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BanophenDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.0f52270a-b11a-4fa1-aac2-9fe5ff6254192026-04-06WarningsExact identifier
ndc (product): 68788-7830

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7830-16878878300115 CAPSULE in 1 BOTTLE (68788-7830-1) 15 capsule2021-01-082028-01-30NoNoCurrent
68788-7830-36878878300330 CAPSULE in 1 BOTTLE (68788-7830-3) 30 capsule2021-01-082028-01-30NoNoCurrent