FDA.reportPublic FDA data

Ibuprofen and Diphenhydramine Citrate

Product NDC
58602-867
11-digit product format
586020867
Labeler code
58602
Product ID
58602-867_21c1f5c5-19fa-4a59-bad3-ea85fd37471b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Diphenhydramine Citrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA216204
Marketing category
ANDA
Marketing start
2022-05-31
Substance
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength
38; 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216204-001IBUPROFEN AND DIPHENHYDRAMINE CITRATEDIPHENHYDRAMINE CITRATE; IBUPROFEN38MG;200MGTABLET / ORAL2022-05-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216204-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2022-05-31a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMAZON BASIC CARE IBUPROFEN PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEAmazon.com Services LLC10ec6386-db13-a9dd-e063-6294a90a82612026-03-18WarningsExact identifier
application applno (ANDA): 216204
application number: ANDA216204
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEBetter Living Brands, LLCfcfb044d-f6b9-5c43-e053-6394a90ac4172024-10-29WarningsExact identifier
application applno (ANDA): 216204
application number: ANDA216204
Ibuprofen PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEKROGER COMPANY15e649c4-d75f-e8c1-e063-6294a90a77472024-07-26WarningsExact identifier
application applno (ANDA): 216204
application number: ANDA216204
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEAurohealth LLC21c1f5c5-19fa-4a59-bad3-ea85fd37471b2022-06-03WarningsExact identifier
application applno (ANDA): 216204
application number: ANDA216204
ndc (product): 58602-867

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen and Diphenhydramine Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN38 mg/1
DIPHENHYDRAMINE CITRATE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup
4OD433S209Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
895664Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
21c1f5c5-19fa-4a59-bad3-ea85fd37471bAvailable on FDA.report

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
58602-867-09Ibuprofen and Diphenhydramine Citrate30 in 1 BOTTLETABLET, COATED301
58602-867-09Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-12Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-12Ibuprofen and Diphenhydramine Citrate40 in 1 BOTTLETABLET, COATED401
58602-867-14Ibuprofen and Diphenhydramine Citrate50 in 1 BOTTLETABLET, COATED501
58602-867-14Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-18Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-18Ibuprofen and Diphenhydramine Citrate80 in 1 BOTTLETABLET, COATED801
58602-867-21Ibuprofen and Diphenhydramine Citrate100 in 1 BOTTLETABLET, COATED1001
58602-867-21Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-23Ibuprofen and Diphenhydramine Citrate120 in 1 BOTTLETABLET, COATED1201
58602-867-23Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-27Ibuprofen and Diphenhydramine Citrate140 in 1 BOTTLETABLET, COATED1401
58602-867-32Ibuprofen and Diphenhydramine Citrate180 in 1 BOTTLETABLET, COATED1801
58602-867-34Ibuprofen and Diphenhydramine Citrate200 in 1 BOTTLETABLET, COATED2001
58602-867-46Ibuprofen and Diphenhydramine Citrate140 in 1 BOTTLE, PLASTICTABLET, COATED1401
58602-867-70Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-70Ibuprofen and Diphenhydramine Citrate40 in 1 BOTTLE, PLASTICTABLET, COATED401
58602-867-72Ibuprofen and Diphenhydramine Citrate80 in 1 BOTTLE, PLASTICTABLET, COATED801
58602-867-72Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-73Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-73Ibuprofen and Diphenhydramine Citrate20 in 1 BOTTLETABLET, COATED201
58602-867-78Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED11
58602-867-78Ibuprofen and Diphenhydramine Citrate50 in 1 BOTTLE, PLASTICTABLET, COATED501
58602-867-80Ibuprofen and Diphenhydramine Citrate200 in 1 BOTTLE, PLASTICTABLET, COATED2001
58602-867-92Ibuprofen and Diphenhydramine Citrate180 in 1 BOTTLE, PLASTICTABLET, COATED1801
58602-867-97Ibuprofen and Diphenhydramine Citrate120 in 1 BOTTLE, PLASTICTABLET, COATED1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-867IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET, COATED [AUROHEALTH LLC]1Current NDC, Legacy NDC, 27 package rows20220605_21c1f5c5-19fa-4a59-bad3-ea85fd37471b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN21c1f5c5-19fa-4a59-bad3-ea85fd37471b1
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD21c1f5c5-19fa-4a59-bad3-ea85fd37471b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-867-09586020867091 BOTTLE in 1 CARTON (58602-867-09) / 30 TABLET, COATED in 1 BOTTLE1 bottle2022-05-310000-00-00NoNoCurrent
58602-867-12586020867121 BOTTLE in 1 CARTON (58602-867-12) / 40 TABLET, COATED in 1 BOTTLE1 bottle2022-05-310000-00-00NoNoCurrent
58602-867-14586020867141 BOTTLE in 1 CARTON (58602-867-14) / 50 TABLET, COATED in 1 BOTTLE1 bottle2022-05-310000-00-00NoNoCurrent
58602-867-18586020867181 BOTTLE in 1 CARTON (58602-867-18) / 80 TABLET, COATED in 1 BOTTLE1 bottle2022-05-310000-00-00NoNoCurrent
58602-867-21586020867211 BOTTLE in 1 CARTON (58602-867-21) / 100 TABLET, COATED in 1 BOTTLE1 bottle2022-05-310000-00-00NoNoCurrent
58602-867-23586020867231 BOTTLE in 1 CARTON (58602-867-23) / 120 TABLET, COATED in 1 BOTTLE1 bottle2022-05-310000-00-00NoNoCurrent
58602-867-2758602086727140 TABLET, COATED in 1 BOTTLE (58602-867-27) 2022-05-310000-00-00NoNoCurrent
58602-867-3258602086732180 TABLET, COATED in 1 BOTTLE (58602-867-32) 2022-05-310000-00-00NoNoCurrent
58602-867-3458602086734200 TABLET, COATED in 1 BOTTLE (58602-867-34) 2022-05-310000-00-00NoNoCurrent
58602-867-4658602086746140 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-46) 2022-05-310000-00-00NoNoCurrent
58602-867-70586020867701 BOTTLE, PLASTIC in 1 CARTON (58602-867-70) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC2022-05-310000-00-00NoNoCurrent
58602-867-72586020867721 BOTTLE, PLASTIC in 1 CARTON (58602-867-72) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC2022-05-310000-00-00NoNoCurrent
58602-867-73586020867731 BOTTLE in 1 CARTON (58602-867-73) / 20 TABLET, COATED in 1 BOTTLE1 bottle2022-05-310000-00-00NoNoCurrent
58602-867-78586020867781 BOTTLE, PLASTIC in 1 CARTON (58602-867-78) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2022-05-310000-00-00NoNoCurrent
58602-867-8058602086780200 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-80) 2022-05-310000-00-00NoNoCurrent
58602-867-9258602086792180 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-92) 2022-05-310000-00-00NoNoCurrent
58602-867-9758602086797120 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-97) 2022-05-310000-00-00NoNoCurrent