FDA.reportPublic FDA data

Application 090397

Type
ANDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFENCAPSULE;ORAL25MG;EQ 200MG FREE ACID AND POTASSIUM SALTNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090397-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2010-11-22a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pain relief pmIBUPROFEN AND DIPHENHYDRAMINE HCLBionpharma Inc.51037299-37dd-ca57-e063-6394a90a12c72026-05-04WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INC.bb7701aa-f482-69e7-e053-2995a90a71b82026-04-17WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 41250-285
Ibuprofen PMIBUPROFEN AND DIPHENHYDRAMINE HCLWhole Foods Market, INC.4db58605-9cc7-e57e-e063-6294a90ab8002026-03-23WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLHEB3fb6c1e5-f877-2cd0-e063-6294a90ae6542026-03-11WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLTARGET Corporation97e2c008-1711-dcba-e053-2995a90aa2ff2025-12-16WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 11673-225
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLKROGER COMPANYca5418f2-4dc0-ad31-e053-2995a90ac1d32025-12-16WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 30142-232
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWALGREEN COMPANY3a193fdb-ab6e-464e-9f13-fda0fa8d50a82023-12-27WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 0363-0207
Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLVALU MERCHANDISERS COMPANYfed2f7ae-2827-f967-e053-6294a90adc0a2023-10-03WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)c62c6319-65eb-37e8-e053-2a95a90a9f902022-12-28WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 36800-237
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWal-Mart Stores, Inc.ba31970a-b952-467c-b3f8-44f7a513de342022-12-28WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 49035-670
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.c483bbd6-934b-660a-e053-2995a90a51b32022-12-27WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 63868-829
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS Pharmacyce4378c0-848e-7878-e053-2a95a90af0f32022-12-27WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 69842-870
pain relief pmIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.58666a5c-fc92-4c8d-9c04-f0c98dc05c562022-12-20WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 69452-264
IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLRite Aid Corporationa35f68f3-c7f8-a55f-e053-2a95a90a90472020-04-15WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 11822-0789
IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.59a97c31-db90-48e1-ac1b-0f7026c8ec942018-11-09WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 69452-205
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLPremier Value Alliance LLC21afce91-afbe-4b38-a8a5-8775148835e82018-10-30WarningsExact identifier
application applno (ANDA): 090397
application number: ANDA090397
ndc (product): 68016-057

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0207Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWALGREEN COMPANYANDACurrent
0363-0207Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWALGREEN COMPANYANDACurrent
0363-0665Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLWalgreensANDACurrent
0363-0665Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLWalgreensANDACurrent
11673-225IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLTARGET CorporationANDACurrent
11673-225IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLTARGET CorporationANDACurrent
11673-265Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTARGET CorporationANDACurrent
11673-265Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTARGET CorporationANDACurrent
11673-265Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTARGET CorporationANDACurrent
11822-0789IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLRite Aid CorporationANDACurrent
30142-232Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLKROGER COMPANYANDACurrent
30142-232Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLKROGER COMPANYANDACurrent
36800-165Ibuprofen PMIbuprofen and Diphenhydramine HClTOP CARE (Topco Associates LLC)ANDACurrent
36800-237Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)ANDACurrent
36800-237Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)ANDACurrent
41250-285Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INC.ANDACurrent
41250-285Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INC.ANDACurrent
49035-065Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-065Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-065Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-670Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWal-Mart Stores, Inc.ANDACurrent
49035-670Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWal-Mart Stores, Inc.ANDACurrent
50804-165Ibuprofen PMIbuprofen and Diphenhydramine HClGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
55315-165Ibuprofen PMIbuprofen and Diphenhydramine HClFreds IncANDACurrent
55910-565Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-565Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-565Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
59726-165Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLP & L Development, LLCANDACurrent
63868-829Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63868-829Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63941-166Ibuprofen PMIbuprofen and Diphenhydramine HClValu Merchandisers Company (Best Choice)ANDACurrent
68016-057Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLPremier Value Alliance LLCANDACurrent
68016-217Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLChain Drug Consortium, LLCANDACurrent
69452-205IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.ANDACurrent
69452-264pain relief pmIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.ANDACurrent
69452-264pain relief pmIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.ANDACurrent
69842-165Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS PharmacyANDACurrent
69842-165Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS PharmacyANDACurrent
69842-870Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS PharmacyANDACurrent
69842-870Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS PharmacyANDACurrent