FDA.reportPublic FDA data

Sleep Aid

Product NDC
72090-020
Requested package NDC
72090-020-10
11-digit product format
720900020
Labeler code
72090
Product ID
72090-020_29ee011c-3b29-40a2-8b9b-ff1f5cb2fb69
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl 25 mg
Dosage form
TABLET
Route
ORAL
Labeler
Pioneer Life Sciences, LLC
Application
M010
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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage72090-02072090-020-10IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage72090-02072090-020-10IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage72090-02072090-020-10IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…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
Sleep Aid
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
a9678fed-bda5-9513-e053-2995a90a25a1Available 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
72090-020-102023-10-25d6a99b39-8fd3-a426-e053-dadaa90af4c2Nighttime Sleep Aid
72090-020-102022-01-28d6a99b39-8fd3-a426-e053-dadaa90af4c2Nighttime Sleep Aid
72090-020-242022-01-28d6a99b39-75e6-a426-e053-dadaa90af4c2a9637ec7-9a71-4023-e053-2995a90ad0da
72090-020-262022-01-28d6a99b39-9027-a426-e053-dadaa90af4c2aa2ce06b-89bc-b998-e053-2995a90a834a
72090-020-252021-01-29ba0f9c33-24e2-a910-e053-dadaa90a0b85Diphenhydramine HCl 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-020-10Sleep Aid100 in 1 BOTTLETABLET1006
72090-020-24Sleep Aid24 in 1 BOTTLETABLET242
72090-020-25Sleep Aid250 in 1 BOTTLETABLET2501
72090-020-26Sleep Aid1 in 1 CARTONTABLET11
72090-020-26Sleep Aid24 in 1 BOTTLETABLET241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-020SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]5Current NDC, Legacy NDC, 1 package rows20240515_a9678fed-bda5-9513-e053-2995a90a25a1.zip
72090-020SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]2Current NDC, Legacy NDC, 1 package rows20200702_a9637ec7-9a71-4023-e053-2995a90ad0da.zip
72090-020SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]1Current NDC, Legacy NDC, 1 package rows20190220_abde2866-8643-424d-9bd6-f967b645eaa2.zip
72090-020SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]1Current NDC, Legacy NDC, 2 package rows20200712_aa2ce06b-89bc-b998-e053-2995a90a834a.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 5 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLEDAMZ789 LLC12dd2419-b2e0-5466-e063-6394a90a42212026-01-07WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE 50mgDIPHENHYDRAMINE HYDROCHLORIDE 50MGAMZ789 LLCaf0b1b08-e269-6399-e053-2a95a90ac12d2026-01-07WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEProdose, Inc.3b1ea33b-8460-31cf-e063-6394a90a55342025-12-31WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDEPIONEER LIFE SCIENCES, LLCc1dab616-c3ff-4d0a-be13-e8dc6b1a26cc2025-12-29WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa9678fed-bda5-9513-e053-2995a90a25a12025-12-29WarningsExact identifier
application number: M010
ndc (package): 72090-020-10
ndc (product): 72090-020
ndc11 (package): 72090002010
sleep patchesSLEEP PATCHESChangsha Maocheng Trading Co., Ltd25eddec9-1713-c2c8-e063-6394a90af02c2025-12-29WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDEPIONEER LIFE SCIENCES, LLC9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa2025-12-29WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLSafeway, Inc.65d1a199-0a8e-41b1-a767-f16e3f91ac942025-12-26WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLSafeway, Inc.837ddc3a-a8d4-454f-974c-979732cb0a222025-12-26WarningsExact identifier
application number: M010
PharbedrylDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.070e556b-e083-452f-8a7c-aca92470dd612025-12-24WarningsExact identifier
application number: M010
PHARBEDRYLDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.a19f1edc-d2cf-45fc-8233-d882441b02472025-12-24WarningsExact identifier
application number: M010
NIGHT TIME SLEEP-AIDDIPHENHYDRAMINE HCLDiscount Drug Martac1860cb-da95-45bf-9261-19f39c56ddfe2025-12-23WarningsExact identifier
application number: M010
SleepAid SoftgelsDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLC963c6925-dfbf-4cdc-8d13-5e10b499c4a92025-12-19WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCL 25 MGNUVICARE LLC85391744-3bf5-428e-a77b-464aa95b3a1a2025-12-19WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY70ec6ac1-2fd8-49dd-9ccb-c16e2f09a2b22025-12-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd337a0e6-09ed-4db0-8883-ec8a5d56bd352025-12-11WarningsExact identifier
application number: M010
Topcare ZZZ SleepDIPHENHYDRAMINE HCLTopco Associates LLC27225d04-6deb-436b-89ea-9842c487292e2025-12-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEHEB91426a5b-dc01-a27b-e053-2a95a90a8ff82025-12-09WarningsExact identifier
application number: M010
Nighttime Sleep Aid, 24-7 Life by 7-ElevenDOXYLAMINE SUCCINATE TABLETLil' Drug Store Products, Inc.457814bc-535c-a136-e063-6394a90af9a42025-12-08WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp97eb3e4d-06b7-49ed-909b-95b523dcce412025-12-05WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNa9678fed-bda5-9513-e053-2995a90a25a16
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDa9678fed-bda5-9513-e053-2995a90a25a16
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNa9637ec7-9a71-4023-e053-2995a90ad0da2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDa9637ec7-9a71-4023-e053-2995a90ad0da2
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNaa2ce06b-89bc-b998-e053-2995a90a834a1
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNabde2866-8643-424d-9bd6-f967b645eaa21
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDaa2ce06b-89bc-b998-e053-2995a90a834a1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDabde2866-8643-424d-9bd6-f967b645eaa21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72090-020-1072090002010100 TABLET in 1 BOTTLE (72090-020-10) 100 tablet2020-06-290000-00-00NoNoCurrent