FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
59779-367
Requested package NDC
59779-367-20
11-digit product format
597790367
Labeler code
59779
Product ID
59779-367_67c81328-f827-43dc-b450-586b72aefc54
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-06-10
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
2027-12-31
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
Nighttime Sleep Aid
Listing expiration
2027-12-31

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
3710254e-6c3c-4044-9694-59703274cd0fAvailable 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
59779-367-08Nighttime Sleep Aid12 in 1 BLISTER PACKTABLET, FILM COATED1222
59779-367-08Nighttime Sleep Aid2 in 1 CARTONTABLET, FILM COATED222
59779-367-12Nighttime Sleep Aid1 in 1 CARTONTABLET, FILM COATED122
59779-367-12Nighttime Sleep Aid100 in 1 BOTTLETABLET, FILM COATED10022
59779-367-20Nighttime Sleep Aid225 in 1 BOTTLE, PLASTICTABLET, FILM COATED22522
59779-367-20Nighttime Sleep Aid1 in 1 CARTONTABLET, FILM COATED122
59779-367-22Nighttime Sleep Aid4 in 1 CARTONTABLET, FILM COATED422
59779-367-22Nighttime Sleep Aid12 in 1 BLISTER PACKTABLET, FILM COATED1222
59779-367-51Nighttime Sleep Aid365 in 1 BOTTLETABLET, FILM COATED36522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-367-12EA - Each59779-367a3cdd023-a461-491f-8d50-e4a46e4e290112023-06-06
59779-367-22EA - Each59779-367de61e3bf-e56d-4011-94ab-2b23573f88e012012-07-24
59779-367-51EA - Each59779-367ce792f0f-a675-4b03-a726-39f4ea2f81c812017-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
TALCINACTIVE INGREDIENT7SEV7J4R1UNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-367NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [CVS PHARMACY]21Current NDC, Legacy NDC, 9 package rows20240627_3710254e-6c3c-4044-9694-59703274cd0f.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 12 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime sleep aid Maximum StrengthDIPHENHYDRAMINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)40e73317-5126-4961-8f28-60899ffbec5a2024-02-20WarningsExact identifier
application number: M010
Nighttime sleep aid Maximum StrengthDIPHENHYDRAMINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)2424fb95-06e2-49e7-aea0-7797a37aef4d2024-02-20WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incf5b609e1-e63b-2e3b-e053-2995a90a76b92024-02-12WarningsExact identifier
application number: M010
Kroger Nighttime Sleep Aid CAPLETDIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.f0f3f58d-9457-4697-98e6-ef52d350cf672024-01-29WarningsExact identifier
application number: M010
Nighttime Sleep AidNIGHTTIME SLEEP AIDAllegiant Health88feea1d-c961-45e9-b9a6-1418b970aaba2024-01-16WarningsExact identifier
application number: M010
Sleep-Aid Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 110, LLC. DBA Leader4283558d-62df-4297-bc85-a4e06681a9202024-01-11WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEDeMoulas Market Basketd3f35102-94ed-4da0-9c29-312e5468fa052023-12-29WarningsExact identifier
application number: M010
nighttime sleep-aidDIPHENHYDRAMINE HCLBionpharma Inc.c0074c77-287e-6c26-e053-2995a90a4d312023-12-26WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYRAMINE HYDROCHLORIDETARGET CORPORATIONfac83dad-f6fd-3316-e053-6394a90a99aa2023-12-21WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENYDRAMINE HYDROCHLORIDETARGET CORPORATIONfc7ed67f-bac9-f9ed-e053-6294a90ad9a12023-12-16WarningsExact identifier
application number: M010
Sleep-Aid, Circle KDIPHENHYDRAMINE HCL CAPLET, 25MGLil' Drug Store Products, Inc.d3ad24c4-44ba-6451-e053-2a95a90a13392023-12-14WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLVALU MERCHANDISERS COMPANYfed2f7ae-2829-f967-e053-6294a90adc0a2023-10-12WarningsExact identifier
application number: M010
Sleep AidSLEEP AIDBetter Living Brands LLC2b730fa5-47f9-468d-86ed-0d49d9cd8dc42023-07-06WarningsExact identifier
application number: M010
Diphenhydramine HCl 25mgSLEEP AIDAllegiant Health2890e4ba-d642-437d-8a86-24996a74e0272021-11-23WarningsExact identifier
application number: M010
Sleep AidSLEEP AIDAllegiant Health9a0b347e-5719-42f3-9050-df5165495e882021-10-14WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAllegiant Healthec57db48-0f3a-4b12-8633-b45a4366c2692020-11-06WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3710254e-6c3c-4044-9694-59703274cd0f22
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3710254e-6c3c-4044-9694-59703274cd0f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59779-367-20597790367201 BOTTLE, PLASTIC in 1 CARTON (59779-367-20) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2000-06-100000-00-00NoNoCurrent