FDA.reportPublic FDA data

Allergy Relief

Product NDC
50844-229
11-digit product format
508440229
Labeler code
50844
Product ID
50844-229_7d50e08f-766e-4d52-a79e-bb467d9c3968
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-18
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
Allergy Relief
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
38df2308-f6f9-4476-ad34-4b5bc5f9fdf2Available 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
50844-229-08Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED127
50844-229-08Allergy Relief2 in 1 CARTONTABLET, FILM COATED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-229ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]6Current NDC, Legacy NDC, 2 package rows20250512_38df2308-f6f9-4476-ad34-4b5bc5f9fdf2.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 170 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERAFLU NIGHTTIME SEVERE COLD AND COUGHACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC5f7f6f70-0f36-4541-89f2-d953259cdb1e2024-01-28WarningsExact identifier
application number: M012
RESFRIOL DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLC0e9c96b9-41ac-0faf-e063-6294a90a8ab52024-01-26WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGood Sensebb709377-7bb3-4931-a2b6-2443aee07c122024-01-26WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC721bfee2-0d3d-4d8b-beee-1ea83064d1c82024-01-23WarningsExact identifier
application number: M012
Sugar Free Cough Drops Honey LemonMENTHOLCardinal Health 110, Inc.fe90dc33-2815-8296-e053-6294a90ac1df2024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCardinal Health 110, Inc.fe91543e-a798-6399-e053-6394a90af5e52024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough Drops Black CherryMENTHOLCardinal Health 110, Inc.fe90cf63-d286-fa5e-e053-6394a90a77592024-01-19WarningsExact identifier
application number: M012
Cough Drops Menthol Honey LemonCOUGH DROPS MENTHOLCardinal Health 110, Inc.fe5b3f6d-2a2d-f322-e053-6394a90aba042024-01-19WarningsExact identifier
application number: M012
Cough Drops MentholMENTHOL COUGH DROPSCardinal Health 110, Inc.fe5b557e-a689-a32c-e053-6294a90aadbd2024-01-19WarningsExact identifier
application number: M012
Cough Drops CherryCHERRY FLAVOR COUGH DROPSCardinal Health 110, Inc.fe5b5e57-1368-c62b-e053-6294a90ae82c2024-01-19WarningsExact identifier
application number: M012
Leader Zinc OxideZINC OXIDECardinal Health 110,Inc.4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d12024-01-18WarningsExact identifier
application number: M012
Cough and Congestion DM Sugar FreeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBest Choice (Valu Merchandisers Company)4656e60e-4733-45c1-bf55-d156e45085c62024-01-17WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLRugby Laboratories775f97c0-6f82-49a8-82ac-f1a73920c3ec2024-01-11WarningsExact identifier
application number: M012
SinuFrin NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Incf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae2024-01-11WarningsExact identifier
application number: M012
SinuFrin Plus NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals, Inc.99afe6a6-1350-49c6-9347-b7e531e359252024-01-11WarningsExact identifier
application number: M012
Childrens Tukol Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.85fe6f0f-41c8-44d3-a34a-355938da5f722024-01-11WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 110, LLC. DBA Leaderad437177-08eb-4811-883f-ac543d5bc58c2024-01-11WarningsExact identifier
application number: M012
Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYaf5053d8-ba02-4cdf-877f-8c1e368dafe02024-01-10WarningsExact identifier
application number: M012
HISTEXTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLCcc466d33-cf3e-4f1c-a794-6d3d79903adf2024-01-08WarningsExact identifier
application number: M012
HISTEX-DMDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC836d062c-29f0-4fd7-b65c-771a3bbd52c42024-01-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN38df2308-f6f9-4476-ad34-4b5bc5f9fdf27
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD38df2308-f6f9-4476-ad34-4b5bc5f9fdf27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-229-08508440229082 BLISTER PACK in 1 CARTON (50844-229-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2022-02-180000-00-00NoNoCurrent