FDA.reportPublic FDA data

HISTAPRIN

Product NDC
50332-0150
11-digit product format
503320150
Labeler code
50332
Product ID
50332-0150_675ce74c-0894-4272-85ba-086f33459a9a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine
Dosage form
TABLET
Route
ORAL
Labeler
NorMed
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
38786a65-a12b-4479-b63c-b7c15410da04Available 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
50332-0150-4HISTAPRIN1 in 1 PACKETTABLET12
50332-0150-4HISTAPRIN50 in 1 BOX, UNIT-DOSETABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0150HISTAPRIN (DIPHENHYDRAMINE) TABLET [NORMED]1Current NDC, 2 package rows20240126_38786a65-a12b-4479-b63c-b7c15410da04.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 3 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERASTAT, CHERRYCHERRY COUGH DROPSHART Healthe3fdd1de-8f28-4063-a590-6c44507dead12025-12-23WarningsExact identifier
application number: M
Crystal Clean Antibacterial HandSoapBENZALKONIUM CHLORIDEChemcor Chemical Corporation308969b5-5ab2-44ef-ac70-9518a5dfbee22025-12-22WarningsExact identifier
application number: M
Foaming Antibacterial HandsoapBENZALKONIUM CHLORIDEChemcor Chemical Corporationeed9b007-0dc1-4954-891f-a7a042e763aa2025-12-22WarningsExact identifier
application number: M
Antibacterial HandsoapBENZALKONIUM CHLORIDEChemcor Chemical Corporation1022be5e-d515-4a06-bf2b-65774ec29a0b2025-12-22WarningsExact identifier
application number: M
Healthy Hands Foaming Hand SanitizerN/AMaintex746650b8-74b7-43f0-bdfc-62a68764f9362025-12-22WarningsExact identifier
application number: M
Chemcor Chemical Foaming Hand SanitizerBENZALKONIUM CHLORIDEChemcor Chemical Corporation5c9d90c1-0381-4237-9529-398fa51b3ab42025-12-22WarningsExact identifier
application number: M
Fresh HandsBENZALKONIUM CHLORIDEMaintexe174083a-8820-4fa7-8cc2-0a2c86f27cd62025-12-22WarningsExact identifier
application number: M
Aluminum HydroxideALUMINUM HYDROXIDEATLANTIC BIOLOGICALS CORP.60a54d4e-89c2-4329-86bf-a288527f37b52025-12-15WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.ff1f6f82-0c7c-4e3f-a2bd-3185e16fa7702025-12-10WarningsExact identifier
application number: M
Health One Pain Relief Cream with Lidocaine 4%PAIN RELIEF CREAM WITH LIDOCAINE 4%ONE2ZEE LIMITED LIABILITY COMPANY46a2276f-9da0-4e41-92f0-b17c302c72222025-12-03WarningsExact identifier
application number: M
Health One Deep Relieving GelDEEP RELIEVING GELONE2ZEE LIMITED LIABILITY COMPANY41d837f1-09e4-4ce3-8c1a-725c2147c7de2025-12-03WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Health87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc2025-12-02WarningsExact identifier
application number: M
AB 3000BENZALKONIUM CHLORIDEChemco892c8911-9f1a-4c0c-9106-6d9a90d577a92025-11-06WarningsExact identifier
application number: M
Strike Bac Antibacterial HandBENZALKONIUM CHLORIDEGenlabs Corporation4014aa67-8016-40c5-88ec-daec9dba4f452025-11-06WarningsExact identifier
application number: M
Metro Antimicrobial HandBENZALKONIUM CHLORIDEMaintexa84d83dd-2445-4d0f-b763-2c69e8248cf92025-11-06WarningsExact identifier
application number: M
Butler Clean HandsBENZALKONIUM CHLORIDEMaintex3fd526a8-d197-4a12-b51b-165e706720a72025-11-06WarningsExact identifier
application number: M
First Street Dishwashing Concentrate and Antibacterial HandBENZALKONIUM CHLORIDEAmerifoods Trading Companyfc81ef1a-db55-411e-8b25-7dd59dd38eda2025-11-06WarningsExact identifier
application number: M
Champion Ultra CleanBENZALKONIUM CHLORIDEMaintex47426f67-af14-4b42-8ada-11b3648269492025-11-06WarningsExact identifier
application number: M
Premium Protection Antibacterial HandBENZALKONIUM CHLORIDEMaintex53bd6860-dde3-4525-ba1b-50f69be09abc2025-11-06WarningsExact identifier
application number: M
Hy-G-ClenzBENZALKONIUM CHLORIDEMicronova Manufacturing, Inc.ce96634e-1ce8-4244-b317-8e1da249de832025-11-06WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN38786a65-a12b-4479-b63c-b7c15410da042
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD38786a65-a12b-4479-b63c-b7c15410da042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50332-0150-45033201500450 PACKET in 1 BOX, UNIT-DOSE (50332-0150-4) / 1 TABLET in 1 PACKET50 packet2023-01-01NoNoCurrent