FDA.reportPublic FDA data

Application 009486

Type
NDA
Sponsor
MCNEIL CONS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENADRYL PRESERVATIVE FREEDIPHENHYDRAMINE HYDROCHLORIDEINJECTABLE;INJECTION50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N009486-001BENADRYL PRESERVATIVE FREEDIPHENHYDRAMINE HYDROCHLORIDE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N009486-001BENADRYL PRESERVATIVE FREE50MG/MLINJECTABLE / INJECTIONRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N009486-001BENADRYL PRESERVATIVE FREE50MG/MLINJECTABLE / INJECTIONRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N009486-001BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…

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 2 of 17 · 333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)047102c4-3d03-4b2d-961d-0ac75980147b2026-05-06WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLCd32d074a-f1b6-4a9a-8e10-e19f0e67c61b2026-05-05Warnings, Adverse reactionsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8d59d121-62a8-c43b-e053-2a95a90a58472026-05-01WarningsName fallback
generic name: DIPHENHYDRAMINE HYDROCHLORIDE
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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
193SUPPL2003-11-05