FDA.reportPublic FDA data

Allergy Relief

Product NDC
72090-021
Requested package NDC
72090-021-10
11-digit product format
720900021
Labeler code
72090
Product ID
72090-021_73414302-0de0-4cb0-9f6d-243b0345a166
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl 25 mg
Dosage form
TABLET
Route
ORAL
Labeler
Pioneer Life Sciences, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-29
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
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
2026-12-31

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
ab45ae97-7951-4058-e053-2995a90a7b2eAvailable 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, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
72090-021-102024-05-13d6a99b39-de89-a426-e053-dadaa90af4c2ab45ed16-86bb-3faf-e053-2995a90acfbc
72090-021-602023-10-25d6a99b39-ac04-a426-e053-dadaa90af4c2ab45ae97-7951-4058-e053-2995a90a7b2e
72090-021-102022-01-28d6a99b39-de89-a426-e053-dadaa90af4c2ab45ed16-86bb-3faf-e053-2995a90acfbc
72090-021-242022-01-28d6a99b39-8fca-a426-e053-dadaa90af4c2a824b04e-1654-28f4-e053-2a95a90ab8bb
72090-021-262022-01-28d6a99b39-418b-a426-e053-dadaa90af4c2a96484ba-c618-ee52-e053-2a95a90a3344
72090-021-602022-01-28d6a99b39-ac04-a426-e053-dadaa90af4c2ab45ae97-7951-4058-e053-2995a90a7b2e
72090-021-252021-01-29ba0f9c33-1a66-a910-e053-dadaa90a0b85Diphenhydramine HCl 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-021-60Allergy Relief600 in 1 BOTTLETABLET6006
72090-021-10Allergy Relief1000 in 1 BOTTLETABLET10003
72090-021-24Allergy Relief24 in 1 BOTTLETABLET241
72090-021-25Allergy Relief250 in 1 BOTTLETABLET2501
72090-021-26Allergy Relief1 in 1 CARTONTABLET11
72090-021-26Allergy Relief24 in 1 BOTTLETABLET241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-021ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]5Current NDC, Legacy NDC, 1 package rows20240522_ab45ae97-7951-4058-e053-2995a90a7b2e.zip
72090-021ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]2Current NDC, Legacy NDC, 1 package rows20240514_ab45ed16-86bb-3faf-e053-2995a90acfbc.zip
72090-021ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]1Current NDC, Legacy NDC, 1 package rows20190220_7c1a38de-555f-46e6-91c5-2d14aa9ab5d1.zip
72090-021ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]1Current NDC, Legacy NDC, 2 package rows20200702_a96484ba-c618-ee52-e053-2a95a90a3344.zip
72090-021ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]1Current NDC, Legacy NDC, 1 package rows20200629_a824b04e-1654-28f4-e053-2a95a90ab8bb.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 91 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TARGET CHILDRENS DT AND NT COLD and COUGHBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLTARGET CORPORATION05ac2a40-5eee-4013-b55b-6e370a28b21c2025-11-05WarningsExact identifier
application number: M012
TARGET CHILDRENs COLD and COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATIONeb912834-1b14-484d-90f7-a8deb52c0d4e2025-11-05WarningsExact identifier
application number: M012
UP and UP Daytime Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationa2d99bc8-7295-4922-acff-0cb02c91273c2025-11-05WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILAMERISOURCE BERGENc1843f1a-ae5b-0fdf-e053-2995a90aae382025-11-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4754363d-e163-42e0-a65d-1c4bac24f6c92025-11-05WarningsExact identifier
application number: M012
Day Time Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLSafeway, Inc.76d62892-615d-4744-95aa-3be1207a0e572025-11-05WarningsExact identifier
application number: M012
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINSafeway, Inc.6fefff08-13b0-47eb-aa32-8d7e4deeae7b2025-11-05WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Eucalyptus 30ctMENTHOLR.L. ALBERT & SON, INC165a8efa-2b03-4329-99fa-3233f0af7d082025-11-04WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INCf9ea46fc-0b04-444e-95fc-09aff7e7978a2025-11-04WarningsExact identifier
application number: M012
QUALITY CHOICE Maximum Strength Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.40413cdb-68ac-70e1-e063-6394a90a92172025-11-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC73fec783-1594-447b-b059-49ea9dbb5bee2025-11-04WarningsExact identifier
application number: M012
Texaclear Fast Acting Allergy ReliefCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATEGM Pharmaceuticals, INC17a2f643-fa98-21ee-e054-00144ff88e882025-11-03WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e618bc7-0f51-e586-e063-6294a90afe372025-11-03WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e61b5b3-ad15-01bf-e063-6394a90a6ec32025-11-03WarningsExact identifier
application number: M012
Cold plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC409540c0-1bab-9969-e063-6394a90a47c12025-11-03WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60b340-bd60-9318-e063-6294a90ad0792025-11-03WarningsExact identifier
application number: M012
Sinus Pressure and Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60e32f-3e5f-b775-e063-6294a90a097d2025-11-03WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e614265-b35a-5d01-e063-6294a90aad852025-11-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60b0ed-889d-0f17-e063-6394a90a46942025-11-03WarningsExact identifier
application number: M012
VANACOF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGM Pharmaceuticals, INC2ed699f2-d004-4fa9-8042-6c85a9ff69b62025-11-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNab45ae97-7951-4058-e053-2995a90a7b2e6
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDab45ae97-7951-4058-e053-2995a90a7b2e6
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNab45ed16-86bb-3faf-e053-2995a90acfbc3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDab45ed16-86bb-3faf-e053-2995a90acfbc3
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN7c1a38de-555f-46e6-91c5-2d14aa9ab5d11
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNa824b04e-1654-28f4-e053-2a95a90ab8bb1
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNa96484ba-c618-ee52-e053-2a95a90a33441
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD7c1a38de-555f-46e6-91c5-2d14aa9ab5d11
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDa824b04e-1654-28f4-e053-2a95a90ab8bb1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDa96484ba-c618-ee52-e053-2a95a90a33441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72090-021-10720900021101000 TABLET in 1 BOTTLE (72090-021-10) 1000 tablet2024-05-130000-00-00NoNoCurrent