Sound Body Childrens Ibuprofen

Product NDC
50594-018
11-digit product format
505940018
Labeler code
50594
Product ID
50594-018_45fc679b-fde2-47e2-8d4e-0fcac50e9546
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Big Lots Stores, Inc.
Application
ANDA074937
Marketing category
ANDA
Marketing start
2016-05-03
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50594-018DDiscontinued by firm2026-07-31
excluded packagepackage50594-01850594-018-26DDiscontinued by firm2026-07-31

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-018SOUND BODY CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [BIG LOTS STORES, INC.]2Legacy NDC20171207_9f01db50-ad65-41e7-81d5-07d5d240673e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50594-018-26505940018261 BOTTLE in 1 CARTON (50594-018-26) > 118 mL in 1 BOTTLE1 bottle2016-05-030000-00-00NoNoCurrent