good sense nighttime sleep aid

Product NDC
0113-0431
11-digit product format
001130431
Labeler code
0113
Product ID
0113-0431_70250c98-1eb2-4522-bdc6-7ce5a1468fda
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-04-25
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0113-04310113-0431-68DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
good sense nighttime 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
ba2adc30-0301-4d53-bce6-fc8b7e34b076Available 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0431-62good sense nighttime sleep aid12 in 1 CARTONTABLET, FILM COATED125
0113-0431-62good sense nighttime sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED25
0113-0431-68good sense nighttime sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED25
0113-0431-68good sense nighttime sleep aid18 in 1 CARTONTABLET, FILM COATED185
0113-0431-78good sense nighttime sleep aid100 in 1 BOTTLETABLET, FILM COATED1005
0113-0431-78good sense nighttime sleep aid1 in 1 CARTONTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0431-62EA - Each0113-04319649502f-c6fa-4d7d-a6f7-a5202e5cda0e12012-07-24
0113-0431-78EA - Each0113-0431f5f22766-f73c-453c-bdb9-0283651b882912024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40GOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0431GOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 6 package rows20240711_ba2adc30-0301-4d53-bce6-fc8b7e34b076.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 1 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HCLDOLGENCORP, LLC2bb3016a-2e03-43fe-a655-45d4ec872c792026-08-05WarningsExact identifier
application number: M010
Sleep TabsDIPHENHYDRAMINE HCLMajor Pharmaceuticalsff8b7346-5be5-4e76-9ee2-d52fab66f6c52026-08-03WarningsExact identifier
application number: M010
MantraMANTRA SLEEP AID WILD CHERRYMOREMED INC.316d11fe-a173-a1dd-e063-6394a90af4992026-07-27WarningsExact identifier
application number: M010
Wal Som Nighttime Sleep AidDIPHENHYDRAMINE HCLWalgreensff475a69-dbb2-40a9-b7f4-9c7b7e975d192026-07-23WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporation336ac29d-db24-44da-a299-5a4793ae8f6a2026-07-21WarningsExact identifier
application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLBEST CHOICE (VALU MERCHANDISERS COMPANY)9bf2d698-8394-46c3-b7a9-e99ab6bb88e42026-07-17WarningsExact identifier
application number: M010
ADWE dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDERARITAN PHARMACEUTICALS INCea3a51af-3025-497f-8cd7-e99391b0d06f2026-07-17WarningsExact identifier
application number: M010
nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLCa8056e5f-e9d8-4555-9212-bf1fa3c154392026-07-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen147adc14-ca7c-45f5-9925-ea569edbfe962026-07-09WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 25 MGHealth Pharma USA LLCd659f747-9790-8bd6-e053-2995a90ae7932026-07-07WarningsExact identifier
application number: M010
PharbedrylDIPHENHYDRAMINE HCLSt. Mary's Medical Park Pharmacy3ef18965-bafb-cc19-e063-6394a90af17d2026-06-29WarningsExact identifier
application number: M010
CalmCo Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC552d0e50-a58c-8e47-e063-6394a90a8f7b2026-06-26WarningsExact identifier
application number: M010
Vicks ZzzQuil Night PainDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENThe Procter & Gamble Manufacturing Companya7cf8e2e-7aac-a1fa-e053-2a95a90a561a2026-06-26WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLBi-Mart1b40e794-089f-4546-8f8d-ba7016cd4e7f2026-06-22WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporation1a5668df-2bbc-4724-af39-19d30a8920f32026-06-22WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLC9f1e2e1f-d3e8-4c8a-9e3e-c2ab9e4c79e82026-06-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTopco Associates, LLC57a81e24-ef0d-4143-b266-71e2d4be76172026-06-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCVS Pharmacy3710254e-6c3c-4044-9694-59703274cd0f2026-06-15WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLWal-Mart Stores Inccfddfdeb-701f-452d-876d-8003e6fcefe32026-06-15WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLFamily Dollar Services Inc2d63400b-43ae-4dd2-b917-3f65e02366b42026-06-08WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNba2adc30-0301-4d53-bce6-fc8b7e34b0765
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDba2adc30-0301-4d53-bce6-fc8b7e34b0765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0431-620011304316212 BLISTER PACK in 1 CARTON (0113-0431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2001-04-250000-00-00NoNoCurrent
0113-0431-680011304316818 BLISTER PACK in 1 CARTON (0113-0431-68) > 2 TABLET, FILM COATED in 1 BLISTER PACK18 blister pack2019-05-210000-00-00NoNoCurrent
0113-0431-78001130431781 BOTTLE in 1 CARTON (0113-0431-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-290000-00-00NoNoCurrent