Diphenhydramine Hydrochloride

Product NDC
0409-2290
11-digit product format
004092290
Labeler code
0409
Product ID
0409-2290_aa445b67-9ac2-492f-9b49-e33b82ab4c76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA040140
Marketing category
ANDA
Marketing start
2005-05-05
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-2290DDiscontinued by firm2026-08-11
excluded productproduct0409-2290DDiscontinued by firm2026-08-11
excluded packagepackage0409-22900409-2290-11DDiscontinued by firm2026-08-11
excluded packagepackage0409-22900409-2290-31DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-2290-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-2290-11d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-2290-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-2290-11f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-2290-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-2290-112ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-2290-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-2290-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-2290-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-2290-11cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-2290-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-2290-11cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-2290-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-2290-11302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-2290-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-2290-11ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-2290-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-2290-110efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-2290-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-2290-11ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-2290-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-2290-11367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-2290-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-2290-11557ba5c1ecfa…9c80585c8c6e…

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
A040140-001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20

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 UTC2026-02A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-203f01610625f2…
2019-09-15 20:21 UTC2019-09A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP1998-11-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040140-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION1998-11-20cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-04 05:41 UTC2022-04A040140-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040140-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040140-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040140-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040140-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040140-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040140-001AP18869cabd3fbd…
2019-12-14 00:12 UTC2019-12A040140-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040140-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040140-001AP1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2290-03ML - Milliliter0409-22907883c166-5f53-4d39-a53e-73a05cfd727d12017-09-11
0409-2290-11ML - Milliliter0409-2290812fa907-7024-4aa4-83aa-91a07608d99d12022-06-06
0409-2290-31ML - Milliliter0409-2290e798365d-9ce4-48d3-9c12-c31706accf6d12012-07-24

DailyMed Socrata Ingredients#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723776diphenhydrAMINE HCl 50 MG in 1 ML CartridgePSN7b05c2ef-24eb-f754-e053-2991aa0afbae3
17237761 ML diphenhydramine hydrochloride 50 MG/ML CartridgeSCD7b05c2ef-24eb-f754-e053-2991aa0afbae3
1723776diphenhydramine HCl 50 MG per 1 ML CartridgeSY7b05c2ef-24eb-f754-e053-2991aa0afbae3