FDA.reportPublic FDA data

Application 087513

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEELIXIR;ORAL12.5MG/5MLNoYes

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
A087513-001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLELIXIR / ORALAARLD, RS1982-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A087513-001AA

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 UTC2022-10A087513-001DIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLELIXIR / ORALRS1982-02-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087513-001DIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLELIXIR / ORALRS1982-02-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087513-001DIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLELIXIR / ORALRS1982-02-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087513-001DIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLELIXIR / ORALAARLD, RS1982-02-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A087513-001AA1c2088c7a36db…
2026-09-14 22:38:342026-08A087513-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A087513-001AA1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087513-001AA1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCLDIPHENHYDRAMINE HYDROCHLORIDERedmont Pharmaceuticals, LLCd8944f3c-acef-4ebe-9633-7d641ae95edf2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087513
application number: ANDA087513
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma6fe6fe2d-4405-4e7a-a2ed-5eb367d528422024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087513
application number: ANDA087513
ndc (product): 0121-0978
ndc (product): 0121-0489
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCbf7ab250-38b0-ba29-e053-2a95a90a8f322023-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087513
application number: ANDA087513
ndc (product): 71872-7242

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
69067-092DiphenDiphenhydramine HydrochlorideFoxland Pharmaceuticals, Inc.ANDACurrent
69067-092DiphenDiphenhydramine HydrochlorideFoxland Pharmaceuticals, Inc.ANDACurrent
71872-7242DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent
73480-150DI-PHENDIPHENHYDRAMINE HYDROCHLORIDETriVue Pharmaceuticals, Inc.ANDACurrent
73480-150DI-PHENDIPHENHYDRAMINE HYDROCHLORIDETriVue Pharmaceuticals, Inc.ANDACurrent