basic care childrens ibuprofen

Product NDC
72288-166
11-digit product format
722880166
Labeler code
72288
Product ID
72288-166_d0f29b6f-d65a-4535-9635-d0bfbfb71cd5
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA074937
Marketing category
ANDA
Marketing start
2021-11-23
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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
A074937-001CHILDREN'S IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22

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 22:54:322026-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22a50c72e98297…

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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens ibuprofenIBUPROFENRite Aid Corporation26bccfc1-bc8d-4241-a078-c760048951c92026-07-24WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENATLANTIC BIOLOGICALS CORP.3ce7549f-e4db-9f89-e063-6294a90a126d2026-07-10WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENRite Aid Corporation1da544eb-ed4e-4124-bea3-f827f13222702026-05-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.52d3e633-13a2-cdcd-e063-6394a90ac1892026-05-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofenIBUPROFENRite Aid Corporation69ca781a-202e-4579-91e6-f32a22ccc22c2026-05-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofen childrensIBUPROFENWalgreen Companyf67612e8-38f3-4d1c-889b-57995a2f9f662026-05-15WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
care one ibuprofenIBUPROFENAmerican Sales Companyd26d2766-6d4c-462b-ae8b-ef8d87acd6332026-04-16WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENCardinal Health 107, LLC9291857c-30b3-414b-99e1-9c127e72c0d42026-04-16WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Ibuprofen childrensIBUPROFENHyVee Inc55f8def6-f7de-4b3e-a92a-5cd9e68a46a12026-04-15WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
CHILDRENS IbuprofenIBUPROFENKesin Pharma Corporation436c0126-4ff3-c082-e063-6294a90a3d722026-04-13WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofen childrensIBUPROFENHyVee Inc3d8497c6-1c46-4248-b75c-b086591529cc2026-04-10WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENCVS Pharmacyef204cc0-4009-4dd0-83e2-2b5ad6f984092026-02-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
equate ibuprofen childrensIBUPROFENWal-Mart Stores Inc7817923f-4c21-4943-a7e2-dad4e2915fc42026-02-23WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofenIBUPROFENHyVee Incc20a9bc5-e481-4fb2-ad10-d01e83e43ca02026-02-21WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Ibuprofen ChildrensIBUPROFENMajor Pharmaceuticals9d56e64d-7860-4fd1-88d2-c537e50079d82026-02-13WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
childrens ibuprofenIBUPROFENHyVee Incd522a3ac-dd43-4faa-b3f8-69313be1c8292026-02-11WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENMajor Pharmaceuticals847758ed-66fc-4db9-8fdb-78f3c3291a032026-01-26WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
good sense ibuprofen childrensIBUPROFENPreferred Pharmaceuticals Inc.7ac61180-d668-4eec-b04f-d14f7b552a4d2025-12-23WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
topcare childrens ibuprofenIBUPROFENTopco Associates LLCd1bb68a6-3a29-4a4e-b4e9-413cc8d161912025-12-12WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.a1a5a9c7-c727-4e41-a8f0-2982f796a3ca2025-09-29WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937

Additional Listing Data#

Finished product
Yes
Brand name base
basic care childrens ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197803Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2a14686-6083-46a1-885c-9f7c30e9c647Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
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
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-166-26basic care childrens ibuprofen120 mL in 1 BOTTLESUSPENSION1202
72288-166-26basic care childrens ibuprofen1 in 1 CARTONSUSPENSION12
72288-166-34basic care childrens ibuprofen240 mL in 1 BOTTLESUSPENSION2402
72288-166-34basic care childrens ibuprofen1 in 1 CARTONSUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-166BASIC CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 4 package rows20211204_b2a14686-6083-46a1-885c-9f7c30e9c647.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNb2a14686-6083-46a1-885c-9f7c30e9c6472
197803ibuprofen 20 MG/ML Oral SuspensionSCDb2a14686-6083-46a1-885c-9f7c30e9c6472
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYb2a14686-6083-46a1-885c-9f7c30e9c6472
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYb2a14686-6083-46a1-885c-9f7c30e9c6472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-166-26722880166261 BOTTLE in 1 CARTON (72288-166-26) / 120 mL in 1 BOTTLE1 bottle2021-11-300000-00-00NoNoCurrent
72288-166-34722880166341 BOTTLE in 1 CARTON (72288-166-34) / 240 mL in 1 BOTTLE1 bottle2021-11-230000-00-00NoNoCurrent