FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
23155-263
Requested package NDC
23155-263-31
11-digit product format
231550263
Labeler code
23155
Product ID
23155-263_8f3f83d2-d97e-4f82-b3e5-f8840fa6b443
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA205337
Marketing category
ANDA
Marketing start
2025-12-15
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
2026-12-31
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
A205337-001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP2025-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205337-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205337-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP2025-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205337-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP2025-11-1431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205337-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP2025-11-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205337-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205337-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205337-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 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
6178d3a1-0741-49a4-be81-c4f7d29f8b2aAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-263-31Diphenhydramine Hydrochloride10 mL in 1 VIAL, GLASSINJECTION105
23155-263-31Diphenhydramine Hydrochloride1 in 1 PACKAGEINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-263-31ML - Milliliter23155-26349dccf22-fe6b-49e2-a3cc-cf4d6801138812026-01-08

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.6178d3a1-0741-49a4-be81-c4f7d29f8b2a2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205337
application number: ANDA205337
ndc (package): 23155-263-31
ndc (product): 23155-263
ndc11 (package): 23155026331

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN6178d3a1-0741-49a4-be81-c4f7d29f8b2a5
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD6178d3a1-0741-49a4-be81-c4f7d29f8b2a5
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSY6178d3a1-0741-49a4-be81-c4f7d29f8b2a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23155-263-31231550263311 VIAL, GLASS in 1 PACKAGE (23155-263-31) / 10 mL in 1 VIAL, GLASS2025-12-15NoNoCurrent