FDA.reportPublic FDA data

Application 070205

Type
ANDA
Sponsor
ALPHARMA US PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRAMINEDIPHENHYDRAMINE HYDROCHLORIDESYRUP;ORAL12.5MG/5MLNoNo

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
A070205-001HYDRAMINEDIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLSYRUP / ORAL1986-01-28

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 22:38:342026-08A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-2884e616aacf4f…
2026-08-18 06:07:402026-07A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070205-001HYDRAMINE12.5MG/5MLSYRUP / ORAL1986-01-28f41ea6bd6efb…

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 3 of 17 · 327 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0203d919-dc1f-cca0-e063-6394a90aa1aa2026-04-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Tecnu CalagelDIPHENHYDRAMINE HYDROCHLORIDETec Laboratories Inc.8bc9cbfe-1dd4-18ed-e053-2a95a90a79662026-04-20WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC5a5c5f33-5b70-465d-a38b-6f518af097882026-04-13WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nightime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBETTER LIVING BRANDS LLC.202bb1ff-3273-4872-e063-6294a90abebb2026-04-11WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Wal Dryl Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEWalgreens09de28cd-fa60-4af7-b7cc-cf74c00a35312026-04-09WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Goodmeds Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.e24121d2-c9d2-4bbd-869e-eeed7e2bb8812026-04-08WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Vicks ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company1be2f00b-5bdd-82e7-e063-6394a90ab9a52026-04-06WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst44217a8c-7656-a0f6-e063-6294a90af2ad2026-03-31WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutionseedb421c-0020-4e5f-8b09-26a1cbabb6812026-03-26Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETWIN MED LLC7b000478-649d-4511-b3e0-eea6995b97842026-03-25WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.01c04bad-3905-4776-b936-7b48ee6699df2026-03-25WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf9a0fb35-46d6-434f-8f9a-425a4bf50e842026-03-18WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.4454df6a-931f-3f03-e063-6294a90afe732026-03-14WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyad4babdb-d98d-420e-b8b0-9a5368c89a442026-03-12WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHEB40091b98-b4c7-4a3b-e063-6294a90abd5d2026-03-10WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINEDIPHENHYDRAMINE HYDROCHLORIDEMicro Labs Limiteda1110433-498a-48cb-ac79-5732fd4f8fba2026-03-05Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company1d608c94-1651-f318-e063-6294a90aa11e2026-03-05WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals04e70311-6412-4a20-84e3-f6e26d5f19ab2026-02-20WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticalsdca04d80-e781-40b1-e053-2995a90a70102026-02-20WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.e33cbd1d-1848-145a-e053-2995a90aeb502026-02-20WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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