FDA.reportPublic FDA data

ZzzQuil ULTRA, Lil Drug Store

Product NDC
66715-9751
11-digit product format
667159751
Labeler code
66715
Product ID
66715-9751_44e705b6-fd79-dd85-e063-6294a90a7d6f
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-26
Substance
DOXYLAMINE SUCCINATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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
ZzzQuil ULTRA, Lil Drug Store
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1101446Internal RxNorm lookup
2548540Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f8c7219-7b40-27c6-e063-6294a90a27d9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9751-2ZzzQuil ULTRA, Lil Drug Store1 in 1 POUCHTABLET13
66715-9751-2ZzzQuil ULTRA, Lil Drug Store2 in 1 CARTONTABLET23
66715-9751-3ZzzQuil ULTRA, Lil Drug Store1 in 1 POUCHTABLET13
66715-9751-3ZzzQuil ULTRA, Lil Drug Store3 in 1 CARTONTABLET33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9751ZZZQUIL ULTRA, TRAVEL BASIX (DOXYLAMINE SUCCINATE) TABLET ZZZQUIL ULTRA, LIL DRUG STORE (DOXYLAMINE SUCCINATE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2Current NDC, 4 package rows20241121_0f8c7219-7b40-27c6-e063-6294a90a27d9.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
1101446doxylamine succinate 25 MG Oral TabletPSN0f8c7219-7b40-27c6-e063-6294a90a27d93
2548540Zzzquil Ultra 25 MG Oral TabletPSN0f8c7219-7b40-27c6-e063-6294a90a27d93
2548540doxylamine succinate 25 MG Oral Tablet [Zzzquil Ultra]SBD0f8c7219-7b40-27c6-e063-6294a90a27d93
1101446doxylamine succinate 25 MG Oral TabletSCD0f8c7219-7b40-27c6-e063-6294a90a27d93
2548540Zzzquil Ultra 25 MG Oral TabletSY0f8c7219-7b40-27c6-e063-6294a90a27d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-9751-2667159751022 POUCH in 1 CARTON (66715-9751-2) / 1 TABLET in 1 POUCH2 pouch2025-09-30NoNoCurrent
66715-9751-3667159751033 POUCH in 1 CARTON (66715-9751-3) / 1 TABLET in 1 POUCH3 pouch2024-01-26NoNoCurrent