FDA.reportPublic FDA data

Diphenhydramine HCl and Ibuprofen

Product NDC
58602-814
11-digit product format
586020814
Labeler code
58602
Product ID
58602-814_8cd3b0a3-8a94-4cca-a6a7-f144a826f122
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl and Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA210676
Marketing category
ANDA
Marketing start
2019-02-14
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
Diphenhydramine HCl and Ibuprofen
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
58602-814-10Diphenhydramine HCl and Ibuprofen32 in 1 BOTTLECAPSULE, LIQUID FILLED325
58602-814-10Diphenhydramine HCl and Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
58602-814-12Diphenhydramine HCl and Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED405
58602-814-12Diphenhydramine HCl and Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
58602-814-18Diphenhydramine HCl and Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
58602-814-18Diphenhydramine HCl and Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED805
58602-814-23Diphenhydramine HCl and Ibuprofen120 in 1 BOTTLECAPSULE, LIQUID FILLED1205
58602-814-30Diphenhydramine HCl and Ibuprofen160 in 1 BOTTLECAPSULE, LIQUID FILLED1605
58602-814-73Diphenhydramine HCl and Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED205
58602-814-73Diphenhydramine HCl and Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-814DIPHENHYDRAMINE HCL AND IBUPROFEN CAPSULE, LIQUID FILLED [AUROHEALTH LLC]5Current NDC, Legacy NDC, 10 package rows20220429_a656f8b0-8cb4-4802-b8d3-7b95c0265d56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901814ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSNa656f8b0-8cb4-4802-b8d3-7b95c0265d565
901814diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral CapsuleSCDa656f8b0-8cb4-4802-b8d3-7b95c0265d565

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-814-10586020814101 BOTTLE in 1 CARTON (58602-814-10) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-02-140000-00-00NoNoCurrent
58602-814-12586020814121 BOTTLE in 1 CARTON (58602-814-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-02-140000-00-00NoNoCurrent
58602-814-18586020814181 BOTTLE in 1 CARTON (58602-814-18) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-02-140000-00-00NoNoCurrent
58602-814-2358602081423120 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-23) 2019-02-140000-00-00NoNoCurrent
58602-814-3058602081430160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-30) 2019-02-140000-00-00NoNoCurrent
58602-814-73586020814731 BOTTLE in 1 CARTON (58602-814-73) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-02-140000-00-00NoNoCurrent