FDA.reportPublic FDA data

Benadryl

Product NDC
50580-370
11-digit product format
505800370
Labeler code
50580
Product ID
50580-370_21716a1f-3636-bdde-e063-6394a90aab01
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
KIT
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-12
NDC exclude flag
No
Listing certified through
2026-12-31
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
Benadryl
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup
1049632Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2884d2dc-2d4a-4ca6-ab73-688a80b428ebAvailable 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-370-012024-02-01C16284748780-11030e365-4375-111a-e063-dadaa90a10e2Benadryl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-370-01Benadryl1 in 1 PACKAGEKIT110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-370BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 1 package rows20241109_2884d2dc-2d4a-4ca6-ab73-688a80b428eb.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 152 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DropsMENTHOLTopco Associates LLCeff16ba3-7e30-aa93-e053-2995a90a64cb2024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.ebf6bcf5-9384-052a-e053-2a95a90a30a52024-10-07WarningsExact identifier
application number: M012
Rompe Pecho SF Flu SF FluBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06eac696-e8f6-ac50-e063-6394a90a2ed62024-10-07WarningsExact identifier
application number: M012
dg health nasal fourPHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCceeeb016-8e46-40b8-9923-8a4270475f452024-10-04WarningsExact identifier
application number: M012
Topcare Nasal FourPHENYLEPHRINE HYDROCHLORIDETopco Associates LLC99bc8829-167b-4cf8-8421-57da369f24cd2024-10-04WarningsExact identifier
application number: M012
basic care nasalPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC858648f6-f454-4008-9ea8-ad060c2178332024-10-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDENavajo Manufacturing Company Inc.f6068011-ad56-59b4-e053-2995a90ac0162024-10-03WarningsExact identifier
application number: M012
Benadryl UltratabsDIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.76433e3c-142c-4704-8b2b-d602f008c3772024-10-02WarningsExact identifier
application number: M012
AfrinOXYMETAZOLINE HYDROCHLORIDENavajo Manufacturing Company Inc.65bf1556-f234-9439-e053-2a91aa0a31942024-10-02WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLProficient Rx LP4eab4344-d95e-4b19-a21e-9c8ad033863a2024-10-01WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLProficient Rx LPa910320b-0585-40bd-928c-0406346281d02024-10-01WarningsExact identifier
application number: M012
CareOne Nasal and Sinus DecongestantPSEUDOEPHEDRINE HCLAmerican Sales Company81b31070-9b03-4ce4-8aac-a334544842ae2024-10-01WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINProficient Rx LP20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d2024-10-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.1bec5167-5fc5-2405-e063-6294a90a53582024-09-30WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutions19b3db33-86d1-48f3-9525-c7c87a4b68992024-09-29WarningsExact identifier
application number: M012
nasal decongestant maximum strength non drowsyPSEUDOEPHEDRINE HCLMeijer Distribution Inc8a68ca99-fd76-409a-9769-88830e8720a82024-09-28WarningsExact identifier
application number: M012
good neighbor pharmacy tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergen58687394-b6d2-4d51-bde0-8f2cfa3fe9092024-09-27WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEAmerisource Bergenfaee3aae-e819-4084-a127-3449be353b132024-09-27WarningsExact identifier
application number: M012
Tesalon ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCLOPMX LLC2309620a-ccbc-41e9-e063-6394a90a95202024-09-26WarningsExact identifier
application number: M012
adult cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.b11c4cee-bbb5-4585-9d38-6787553e13a02024-09-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049632Benadryl 25 MG Oral TabletPSN2884d2dc-2d4a-4ca6-ab73-688a80b428eb10
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2884d2dc-2d4a-4ca6-ab73-688a80b428eb10
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD2884d2dc-2d4a-4ca6-ab73-688a80b428eb10
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2884d2dc-2d4a-4ca6-ab73-688a80b428eb10
1049632Benadryl 25 MG Oral TabletSY2884d2dc-2d4a-4ca6-ab73-688a80b428eb10
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY2884d2dc-2d4a-4ca6-ab73-688a80b428eb10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-370-01505800370011 KIT in 1 PACKAGE (50580-370-01) * 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE * 4 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK1 kit2017-06-120000-00-00NoNoCurrent