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 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
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

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