FDA.reportPublic FDA data

Rest Simply

Product NDC
63868-772
11-digit product format
638680772
Labeler code
63868
Product ID
63868-772_3413d808-fba3-6221-e063-6394a90ab654
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-13
Marketing end
2027-08-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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
Rest Simply

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
54bdb6bc-622c-412a-8365-a1b1c968e13eAvailable 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
63868-772-10Rest Simply1 in 1 CARTONTABLET, COATED14
63868-772-10Rest Simply100 in 1 BOTTLE, PLASTICTABLET, COATED1004
63868-772-24Rest Simply2 in 1 CARTONTABLET, COATED24
63868-772-24Rest Simply12 in 1 BLISTER PACKTABLET, COATED124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-772-10EA - Each63868-772fc06005b-0ccd-4b8f-bd2c-dfc02562b8db12022-09-12
63868-772-24EA - Each63868-772c95fb48b-d509-4e90-819a-83b3f5abe76b12022-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40REST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MREST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JREST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48REST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDREST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOREST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AREST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HREST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4REST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPREST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-772REST SIMPLY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]4Current NDC, Legacy NDC, 4 package rows20250502_54bdb6bc-622c-412a-8365-a1b1c968e13e.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 7 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYe96ec4d4-53b9-4636-a58c-1a5923a021ad2025-10-31WarningsExact identifier
application number: M010
GOODNOW SLEEP AIDDIPHENHYDRAMINE HCLGobrands, Inc7d821b7d-6a31-4ff7-b587-51907ba626582025-10-29WarningsExact identifier
application number: M010
SominexDIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.f7858ecf-8498-4465-85d8-3e78147375732025-10-23WarningsExact identifier
application number: M010
Sominex MaxDIPHENHYDRAMINE HCLMedtech Products Inc.e8f6991f-c47a-4d12-934b-04fdf092dac32025-10-23WarningsExact identifier
application number: M010
equate NIGHTTIME Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.3d3f2e0c-e141-d49f-e063-6394a90ad0e62025-10-21WarningsExact identifier
application number: M010
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH6fe34d05-84a4-4254-aea6-77b52122ea182025-10-14WarningsExact identifier
application number: M010
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH68c79c47-11bf-4b51-ace0-723cac7a46202025-10-14WarningsExact identifier
application number: M010
InstaRelief Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEDXM Pharmacuetical, Inc.e0459e71-32dd-4715-b103-bb14db42c5f32025-10-06WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)1eb2e4d7-1572-4c0c-888b-342831298cad2025-10-03WarningsExact identifier
application number: M010
AXIV - VroZzzDIPHENHYDRAMINE HYDROCHLORIDEVivunt Pharma LLC131a60cf-02ec-5a5b-e063-6294a90abd1f2025-09-17WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)485ce8ae-c2b7-462f-9c08-8594cd121f0c2025-09-11WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEWALGREENS35b78063-e717-2ccb-e063-6394a90a18eb2025-09-04WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationded84160-8f6a-4ad1-93be-efbf3a6c3b8f2025-09-03WarningsExact identifier
application number: M010
QUALITY CHOICE NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)3ce00c99-1a9b-41f1-a99a-35e03730dff02025-08-23WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBJWC (Berkley & Jensen / BJ's)2f476647-5727-3443-e063-6394a90afd3f2025-08-19WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBJWC (Berkley & Jensen / BJ's)2f477706-0ce2-97b0-e063-6294a90a5c8e2025-08-19WarningsExact identifier
application number: M010
Nighttime Sleep AidNIGHTTIME SLEEP AIDAllegiant Health407ff0ee-41a3-4dea-95c8-556f664e115e2025-08-06WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLH E B1069961c-ed3b-471f-a632-81024c37dbd92025-08-04WarningsExact identifier
application number: M010
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC2ea0b2cf-f055-11f6-e063-6394a90a53642025-08-01WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLGood Sense (Geiss, Destin & Dunn, Inc.)135482d0-5264-4c81-b43b-8fc931bb02e82025-07-30WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN54bdb6bc-622c-412a-8365-a1b1c968e13e4
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD54bdb6bc-622c-412a-8365-a1b1c968e13e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-772-10638680772101 BOTTLE, PLASTIC in 1 CARTON (63868-772-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2014-06-132027-08-31NoNoCurrent
63868-772-24638680772242 BLISTER PACK in 1 CARTON (63868-772-24) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2014-06-132026-10-31NoNoCurrent