FDA.reportPublic FDA data

Application 087977

Type
ANDA
Sponsor
LNK

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
A087977-001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27

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 22:38:342026-08A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-2784e616aacf4f…
2026-08-18 06:07:402026-07A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087977-001DIPHENHYDRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL1983-01-27f41ea6bd6efb…

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 7 of 17 · 328 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHenry Schein, Inc.af972e71-62ab-40c6-925a-cbcb4d6720a42025-10-30Warnings, Adverse reactionsName fallback
brand name: Diphenhydramine Hydrochloride
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDESAM'S WEST INC16592ad7-b7cb-0837-e063-6394a90ae0592025-10-29WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWAL-MART STORES INC.3652ee94-b762-4100-a305-5acbec5f795a2025-10-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEMeijer Distribution Inc622b12fa-455c-4432-a9a2-698a929bbd682025-10-24WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Meijer Nighttime Sleep-aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEMEIJER DISTRIBUTION INCc7258241-2966-4876-918b-84bbf50ec4bc2025-10-24WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Meijer Nighttime Sleep Aid Non Habit FormingDIPHENHYDRAMINE HYDROCHLORIDEMEIJER DISTRIBUTION INCfd476bfa-3e2e-470c-9180-19aa43e4af242025-10-24WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
SominexDIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.f7858ecf-8498-4465-85d8-3e78147375732025-10-23WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nyt Time Sleep CapsDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MARTe3f4d063-921d-4503-89a6-26cc9c46b4c92025-10-23WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEMethod Pharmaceuticals, LLC5a60c923-8bb7-427f-9636-08ed5474f71b2025-10-21WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
equate NIGHTTIME Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.3d3f2e0c-e141-d49f-e063-6394a90ad0e62025-10-21WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH6fe34d05-84a4-4254-aea6-77b52122ea182025-10-14WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH68c79c47-11bf-4b51-ace0-723cac7a46202025-10-14WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
InstaRelief Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEDXM Pharmacuetical, Inc.e0459e71-32dd-4715-b103-bb14db42c5f32025-10-06WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3dd5b783-5b64-24b5-e063-6394a90ab4ee2025-10-02WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Xpect Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDECintas Corporationa373b2c3-5c58-4b64-9358-bdf42dfce08c2025-09-24WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2025-09-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
AXIV AllergyDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1323a67c-b9c5-038c-e063-6394a90a5e6b2025-09-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
AXIV - VroZzzDIPHENHYDRAMINE HYDROCHLORIDEVivunt Pharma LLC131a60cf-02ec-5a5b-e063-6294a90abd1f2025-09-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPrecision Dose, Inc.4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea42025-09-12WarningsName fallback
brand name: Diphenhydramine Hydrochloride
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Medique DiphenDIPHENHYDRAMINE HYDROCHLORIDEUnifirst First Aid Corporationb61ee2e0-2543-447d-9fc4-23363d46ce042025-09-08WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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