Diphenhydramine Hydrochloride

Product NDC
50090-0878
Requested package NDC
50090-0878-0
11-digit product format
500900878
Labeler code
50090
Product ID
50090-0878_3e351041-092e-4928-afd5-798f66c4dc9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA080817
Marketing category
ANDA
Marketing start
1972-11-27
Substance
DIPHENHYDRAMINE HCL
Active strength
50 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A080817-002DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A080817-002AP

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 UTC2026-02A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080817-002DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A080817-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080817-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080817-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080817-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080817-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080817-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080817-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080817-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080817-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080817-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080817-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080817-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080817-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080817-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080817-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080817-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080817-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080817-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080817-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080817-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080817-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A080817-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080817-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080817-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080817-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A080817-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080817-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080817-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080817-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080817-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080817-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080817-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080817-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080817-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080817-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080817-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080817-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080817-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080817-002AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080817-002AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HCL50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049633Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eedb421c-0020-4e5f-8b09-26a1cbabb681Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0878-0Diphenhydramine Hydrochloride1 in 1 CARTONINJECTION16
50090-0878-0Diphenhydramine Hydrochloride50 mL in 1 VIALINJECTION506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0878-0ML - Milliliter50090-0878b5064197-a96b-4726-b8e7-137560716d9712021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0878DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20230208_eedb421c-0020-4e5f-8b09-26a1cbabb681.zip

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESportpharm LLCe5af2dd2-cc91-46c7-bdb9-97a7cdddcb692026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLCd32d074a-f1b6-4a9a-8e10-e19f0e67c61b2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutionseedb421c-0020-4e5f-8b09-26a1cbabb6812026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
ndc (package): 50090-0878-0
ndc (product): 50090-0878
ndc11 (package): 50090087800
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutions5af966ae-535b-492b-ba2c-eeb4e40be9592026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEREMEDYREPACK INC.62edde3d-b41b-40fc-ac18-b749035de8312026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHenry Schein, Inc.af972e71-62ab-40c6-925a-cbcb4d6720a42025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEREMEDYREPACK INC.b39836d7-2d3a-4a0f-88dc-ca230c82d2a12025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.829bbcbf-fb27-4484-aff6-a7e7467670af2025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ec691492-a295-4b48-a1a3-5824931efa972024-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co. LLC, DBA Health First738f2ce3-520c-b3a2-e053-2a91aa0af3242024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6671c8d0-1f5d-0d77-e053-2a91aa0a75852023-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080817
application number: ANDA080817

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNeedb421c-0020-4e5f-8b09-26a1cbabb6816
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDeedb421c-0020-4e5f-8b09-26a1cbabb6816
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYeedb421c-0020-4e5f-8b09-26a1cbabb6816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0878-0500900878001 VIAL in 1 CARTON (50090-0878-0) / 50 mL in 1 VIAL1 vial2014-11-280000-00-00NoNoCurrent