FDA.reportPublic FDA data

Application 089488

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDECAPSULE;ORAL25MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A089488-001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-0284e616aacf4f…
2026-08-18 06:07:402026-07A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-023f01610625f2…
2019-09-15 20:21 UTC2019-09A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089488-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1987-01-02f41ea6bd6efb…

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 17 · 328 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEHyVee Inc496ce4ba-08a9-ee99-e063-6294a90ac9a72026-08-21WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9713d8ee-6ab2-2fdf-e053-2a95a90a9e192026-08-19Warnings, Adverse reactionsName fallback
brand name: DIPHENHYDRAMINE HYDROCHLORIDE
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsName fallback
brand name: Diphenhydramine Hydrochloride
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Winco Foods Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLCa1367804-37c9-4906-858f-8feeb748d8d32026-08-07WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HCLDIPHENHYDRAMINE HYDROCHLORIDERedmont Pharmaceuticals, LLCd8944f3c-acef-4ebe-9633-7d641ae95edf2026-08-03Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DG Health Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inced754d5c-74e1-4dee-a5c5-10ccec1b81db2026-08-03WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Good Neighbor Pharmacy allergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergen9819522f-f3db-4cb8-9680-423114ace2f62026-07-31WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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