FDA.reportPublic FDA data

Ibuprofen PM

Product NDC
21130-056
11-digit product format
211300056
Labeler code
21130
Product ID
21130-056_792e598a-eaee-4d0a-9c99-154ecbf29aaf
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Citrate, Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Safeway, Inc.
Application
ANDA211404
Marketing category
ANDA
Marketing start
2024-03-01
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen PM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE CITRATE38 mg/1
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4OD433S209, WK2XYI10QM
Rxcui895664

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-056-402026-01-05C16284748780-12cef2736-8bf4-d83d-e063-dadaa90ab31fDrug Facts
21130-056-802026-01-05C16284748780-12cef2736-8bf4-d83d-e063-dadaa90ab31fDrug Facts
21130-056-402025-01-30C16284748780-12cef2736-8bf4-d83d-e063-dadaa90ab31fDrug Facts
21130-056-802025-01-30C16284748780-12cef2736-8bf4-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-056-40Ibuprofen PM1 in 1 BOXTABLET, COATED17
21130-056-40Ibuprofen PM40 in 1 BOTTLE, PLASTICTABLET, COATED407
21130-056-80Ibuprofen PM80 in 1 BOTTLE, PLASTICTABLET, COATED807
21130-056-80Ibuprofen PM1 in 1 BOXTABLET, COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-056IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [SAFEWAY, INC.]6Current NDC, 4 package rows20240412_e49d1e9e-99a6-4d81-90d6-ef23a584a3d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNe49d1e9e-99a6-4d81-90d6-ef23a584a3d17
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDe49d1e9e-99a6-4d81-90d6-ef23a584a3d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-056-40211300056401 BOTTLE, PLASTIC in 1 BOX (21130-056-40) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC2024-03-012026-12-31NoNoHistorical
21130-056-80211300056801 BOTTLE, PLASTIC in 1 BOX (21130-056-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC2024-03-012026-12-31NoNoHistorical