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 4 of 17 · 327 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companye441c952-cd48-4159-ada2-271ca75416002026-02-20WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutions5af966ae-535b-492b-ba2c-eeb4e40be9592026-02-11Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services, LLC1d6c23d7-d1dc-4cba-8600-5762c18a0e272026-01-29WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED32074a31-326b-4aaf-e063-6394a90a0d402026-01-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED335b6ddd-fdc8-1120-e063-6394a90add412026-01-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0e45d0e8-3741-7cee-e063-6394a90a2de52026-01-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd335b09c6-ee5d-ebdf-e063-6294a90abd122026-01-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd32033991-a4f0-f767-e063-6394a90a0b062026-01-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Inc90506598-046f-48d3-b8f5-d6ead03338122026-01-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DORMMY-LONDIPHENHYDRAMINE HYDROCHLORIDEHaendel Farma, S.A. de C.V.562db961-83cb-4b74-9f34-fecee2c1be172026-01-27WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEProdose, Inc.c4bc3efd-8ca8-22fe-e053-2a95a90aed452026-01-26WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb9fbf917-12b7-770f-e053-2995a90afe932026-01-26WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYf000d0b5-8ee8-4db0-99fe-aae5ed20c98e2026-01-19WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens37853689-c9ca-4bc7-9c5b-4a68b8d778be2026-01-19WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DimetaneDIPHENHYDRAMINE HYDROCHLORIDERising Pharma Holdings, Inc.484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f2026-01-19WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Walgreen Itch Relief GelDIPHENHYDRAMINE HYDROCHLORIDEWalgreens5aca3297-406f-4165-9895-c58ccffb374f2026-01-15WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Quality Choice Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association4b86101c-00f8-4ede-807f-db4273b37b8d2026-01-15WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEREMEDYREPACK INC.62edde3d-b41b-40fc-ac18-b749035de8312026-01-14Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.9105f4f1-7f94-408d-a025-83afb68dc9f02026-01-14WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e608643-1a74-b474-e063-6294a90ad2e02026-01-13WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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