FDA.reportPublic FDA data

DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
42571-511
Requested package NDC
42571-511-56
11-digit product format
425710511
Labeler code
42571
Product ID
42571-511_3d083da4-429e-73c5-e063-6394a90ad2c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Micro Labs Limited
Application
ANDA219845
Marketing category
ANDA
Marketing start
2025-11-01
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
A219845-001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP2025-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219845-001AP

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 UTC2026-02A219845-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP2025-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219845-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP2025-08-2231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219845-001DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAP2025-08-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219845-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219845-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219845-001AP1a50c72e98297…

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
c2981222-1671-4ecd-a5a2-286f0663f1aeAvailable 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
42571-511-56DIPHENHYDRAMINE HYDROCHLORIDE1 in 1 CARTONINJECTION11
42571-511-56DIPHENHYDRAMINE HYDROCHLORIDE10 mL in 1 VIAL, GLASSINJECTION101

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 HYDROCHLORIDEMicro Labs Limitedc2981222-1671-4ecd-a5a2-286f0663f1ae2025-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219845
application number: ANDA219845
ndc (package): 42571-511-56
ndc (product): 42571-511
ndc11 (package): 42571051156

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNc2981222-1671-4ecd-a5a2-286f0663f1ae1
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDc2981222-1671-4ecd-a5a2-286f0663f1ae1
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYc2981222-1671-4ecd-a5a2-286f0663f1ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42571-511-56425710511561 VIAL, GLASS in 1 CARTON (42571-511-56) / 10 mL in 1 VIAL, GLASS2025-11-01NoNoCurrent