FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
41226-793
11-digit product format
412260793
Labeler code
41226
Product ID
41226-793_576e6ed3-5559-2480-e063-6294a90a02e6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Kroger
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-05
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
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 HYDROCHLORIDE50 mg/30mL

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
1248354Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
514aa6b5-c33b-494c-e063-6294a90a7aceAvailable on FDA.report

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 6 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unisom SleepMelts Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f50cc038-0973-4c4b-84a7-1c68f41c24102025-12-04WarningsExact identifier
application number: M010
Walgreens ChildrensNIGHTTIME COUGHWALGREENS CO.a270cbe3-bf0a-44da-9359-00e218eba2392025-12-01WarningsExact identifier
application number: M010
ZzzQuil ULTRA, Travel BASIXDOXYLAMINE SUCCINATELil' Drug Store Products, Inc.0f8c7219-7b40-27c6-e063-6294a90a27d92025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLBIONPHARMA INC.141b00b7-a283-40ab-e063-6294a90aec772025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLBIONPHARMA INC.1f74e760-9ba9-ac47-e063-6394a90acdff2025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLDISCOUNT DRUG MART, INC.116e8192-0c2f-39ed-e063-6294a90abaf32025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLAMERISOURCE BERGEN16b2edd2-c16b-5713-e063-6394a90acf462025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLVALU MERCHANDISERS COMPANY08a38cd2-04ae-1ef9-e063-6294a90a88682025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLKROGER COMPANY0f2c1c6a-29bc-e4a8-e063-6394a90a28cb2025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLWhole Foods Market, INC.35acf7d9-e567-996d-e063-6394a90a1cf62025-12-01WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANY048cfa3a-4519-400d-a5ab-ce05c9cc4ec82025-11-26WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfe58ce40-ae88-4dc5-9486-e67041f6d8522025-11-26WarningsExact identifier
application number: M010
nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEH E Bb72c47a3-cae3-4b98-ae85-e1313b6fd5012025-11-25WarningsExact identifier
application number: M010
Nighttime Wal Flu Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEWALGREEN CO.e88f7777-9987-4e3c-a3d5-3da60f190bfd2025-11-25WarningsExact identifier
application number: M010
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALGREENS CO807e8ace-2901-4c5f-96dc-04c755484b952025-11-25WarningsExact identifier
application number: M010
SleepDIPHENHYDRAMINE HCLSalado Sales, Inc.837c02dd-971b-4451-98d8-9c438c9db6962025-11-24WarningsExact identifier
application number: M010
Nighttime SleepAidDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANY3802d57e-7943-c0c2-e063-6394a90a75802025-11-20WarningsExact identifier
application number: M010
Sleep-Aid NighttimeDIPHENHYDRAMINE HCLCVS PHARMACY6bd1ad2e-8f47-412d-8620-b149ad90c2922025-11-17WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporationf8d50b4e-735d-4d91-a18d-be3537e46e992025-11-15WarningsExact identifier
application number: M010
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDECompany name: Topco Associates, LLC7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec2025-10-31WarningsExact identifier
application number: M010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41226-793-02412260793022 BOTTLE in 1 PACKAGE (41226-793-02) / 354 mL in 1 BOTTLE (41226-793-01) 2 bottle2026-09-05NoNoCurrent