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 102 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AXIV NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC131f6314-c9a1-7af3-e063-6294a90abe6f2025-09-17WarningsExact identifier
application number: M012
AXIV DayTime - NightTime 48 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC1320e243-344f-98ed-e063-6294a90a00922025-09-17WarningsExact identifier
application number: M012
AXIV Sinus Severe MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDEVIVUNT PHARMA LLC13245298-8b78-e177-e063-6294a90a6bec2025-09-17WarningsExact identifier
application number: M012
GoodSense Tussin CF Multi-Symptom Cold, RaspberryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.3f05cf84-d485-7688-e063-6394a90ae7402025-09-17WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)5d7466b4-fdb7-432b-880d-e7aa4a4acbda2025-09-17WarningsExact identifier
application number: M012
allergy relief ChildrensDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIe34d8bf5-e12e-453c-93ea-9c7988c4f13d2025-09-16WarningsExact identifier
application number: M012
DayTime Cold Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f2025-09-16WarningsExact identifier
application number: M012
DOMETUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDomel Laboratories3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe2025-09-16WarningsExact identifier
application number: M012
CareOne Severe Congestion NasalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companyd1dba68b-c4e1-4afc-9aee-6a51341b89f52025-09-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)e69ef8dc-09d2-46de-aebf-ba735f4cc7ea2025-09-16WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3ea9a1f2-75b3-c67a-e063-6294a90a8caf2025-09-13WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3eab4cf9-6fdc-a6fb-e063-6394a90a86332025-09-13WarningsExact identifier
application number: M012
COLD AND FLU DAYTIME-NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9fab3-890a-158d-e053-2a95a90af4232025-09-13WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPrecision Dose, Inc.4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea42025-09-12WarningsExact identifier
application number: M012
Nasal Spray, Circle KOXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTIONLil' Drug Store Products, Inc.3ea06e88-a2c6-621b-e063-6294a90a10752025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHarris Teeter, LLCa0090dc6-0fe5-4ab2-a2cf-6ed19892f3632025-09-12WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCICVS Pharmacyebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e2025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)8d7bb31b-a47d-4252-a0a7-79d286179fb92025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)150e5c3a-7c86-4b66-af30-a376df6974012025-09-12WarningsExact identifier
application number: M012
SEVERE COUGH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED67f8d405-a2ad-4ade-93b4-9b09a0d81d8e2025-09-11WarningsExact 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