FDA.reportPublic FDA data

Application 087978

Type
ANDA
Sponsor
LNK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDECAPSULE;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A087978-001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / 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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087978-001DIPHENHYDRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL1983-01-27e64feba35796…

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 · 334 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADER519c86dd-fa86-5de2-e063-6394a90a462b2026-08-14WarningsName 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
allergyDIPHENHYDRAMINE HYDROCHLORIDEMeijer Distribution Incf1e83e43-011c-4470-bd55-fb2818a9fc842026-07-30WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESportpharm LLCe5af2dd2-cc91-46c7-bdb9-97a7cdddcb692026-07-23Warnings, Adverse reactionsName fallback
brand name: Diphenhydramine Hydrochloride
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.879a7804-f3d4-4a3d-bc92-b473499d6c952026-07-17WarningsName fallback
brand name: Diphenhydramine Hydrochloride
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ADWE dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDERARITAN PHARMACEUTICALS INCea3a51af-3025-497f-8cd7-e99391b0d06f2026-07-17WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE