FDA.reportPublic FDA data

Ibuprofen PM

Product NDC
55319-197
11-digit product format
553190197
Labeler code
55319
Product ID
55319-197_bf93acc7-e377-45cc-b9f4-269b516e0c6a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Citrate, Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA211404
Marketing category
ANDA
Marketing start
2024-03-01
Substance
IBUPROFEN; DIPHENHYDRAMINE CITRATE
Active strength
200; 38 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 43.

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
A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATEDIPHENHYDRAMINE CITRATE; IBUPROFEN38MG;200MGTABLET / ORAL2024-04-11

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
2026-09-14 22:38:342026-08A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-1184e616aacf4f…
2026-08-18 06:07:402026-07A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-118072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211404-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2024-04-11a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen PM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1
DIPHENHYDRAMINE CITRATE38 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
e01be0d7-e16d-44f1-9a0c-251ff9a65d28Available 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
55319-197-20Ibuprofen PM1 in 1 BOXTABLET, COATED17
55319-197-20Ibuprofen PM20 in 1 BOTTLE, PLASTICTABLET, COATED207
55319-197-40Ibuprofen PM40 in 1 BOTTLE, PLASTICTABLET, COATED407
55319-197-40Ibuprofen PM1 in 1 BOXTABLET, COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-197IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [FAMILY DOLLAR (FAMILY WELLNESS)]6Current NDC, 4 package rows20240412_e01be0d7-e16d-44f1-9a0c-251ff9a65d28.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENWALMART INC. (see also Equate)d86151b6-d5c5-4d93-9cfd-43ab7ad0443a2026-08-12WarningsExact identifier
application applno (ANDA): 211404
application number: ANDA211404
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENSafeway, Inc.e49d1e9e-99a6-4d81-90d6-ef23a584a3d12026-01-05WarningsExact identifier
application applno (ANDA): 211404
application number: ANDA211404
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENFamily Dollar (FAMILY WELLNESS)e01be0d7-e16d-44f1-9a0c-251ff9a65d282025-10-22WarningsExact identifier
application applno (ANDA): 211404
application number: ANDA211404
ndc (product): 55319-197
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENWR Group, Inc.1e2feaf0-7fff-43d5-bcfe-9f2851bdc8052025-03-25WarningsExact identifier
application applno (ANDA): 211404
application number: ANDA211404
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mgIBUPROFEN, DIPHENHYDRAMINE CITRATEPLD Acquisitions LLC DBA Avma Pharma Solutionsa7d729bf-6d7a-415a-a414-cae0ba6d00632024-04-24WarningsExact identifier
application applno (ANDA): 211404
application number: ANDA211404

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNe01be0d7-e16d-44f1-9a0c-251ff9a65d287
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDe01be0d7-e16d-44f1-9a0c-251ff9a65d287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55319-197-20553190197201 BOTTLE, PLASTIC in 1 BOX (55319-197-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC2024-03-01NoNoCurrent
55319-197-40553190197401 BOTTLE, PLASTIC in 1 BOX (55319-197-40) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC2024-03-01NoNoCurrent