FDA.reportPublic FDA data

IBUPROFEN, DIPHENHYDRAMINE HCL

Product NDC
69452-205
11-digit product format
694520205
Labeler code
69452
Product ID
69452-205_0f6b5911-edb2-4e3a-b121-45c609b4c60e
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN, DIPHENHYDRAMINE HCL
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA090397
Marketing category
ANDA
Marketing start
2018-11-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active strength
25; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IBUPROFEN, DIPHENHYDRAMINE HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, WK2XYI10QM
Rxcui901814

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-205-04IBUPROFEN, DIPHENHYDRAMINE HCL6 in 1 BLISTER PACKCAPSULE, LIQUID FILLED61
69452-205-04IBUPROFEN, DIPHENHYDRAMINE HCL1 in 1 CARTONCAPSULE, LIQUID FILLED11
69452-205-11IBUPROFEN, DIPHENHYDRAMINE HCL20 in 1 BOTTLECAPSULE, LIQUID FILLED201
69452-205-15IBUPROFEN, DIPHENHYDRAMINE HCL40 in 1 BOTTLECAPSULE, LIQUID FILLED401
69452-205-20IBUPROFEN, DIPHENHYDRAMINE HCL100 in 1 BOTTLECAPSULE, LIQUID FILLED1001
69452-205-78IBUPROFEN, DIPHENHYDRAMINE HCL80 in 1 BOTTLECAPSULE, LIQUID FILLED801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-205IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [BIONPHARMA INC.]1Current NDC, Legacy NDC, 6 package rows20181110_59a97c31-db90-48e1-ac1b-0f7026c8ec94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901814ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSN59a97c31-db90-48e1-ac1b-0f7026c8ec941
901814diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral CapsuleSCD59a97c31-db90-48e1-ac1b-0f7026c8ec941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-205-04694520205041 BLISTER PACK in 1 CARTON (69452-205-04) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2018-11-010000-00-00NoNoCurrent
69452-205-116945202051120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-11) 2018-11-010000-00-00NoNoCurrent
69452-205-156945202051540 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-15) 2018-11-010000-00-00NoNoCurrent
69452-205-2069452020520100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-20) 2018-11-010000-00-00NoNoCurrent
69452-205-786945202057880 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-78) 2018-11-010000-00-00NoNoCurrent