FDA.reportPublic FDA data

basic care nighttime sleep aid

Product NDC
72288-186
11-digit product format
722880186
Labeler code
72288
Product ID
72288-186_c0267679-46c6-4c16-be29-97c263c4f9eb
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Amazon.com Services LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-06
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
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
basic care nighttime sleep aid
Listing expiration
2026-12-31

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
027de5ea-5c07-4960-8a98-8cf2c0e54a92Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-186-40basic care nighttime sleep aid355 mL in 1 BOTTLESOLUTION3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-186BASIC CARE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 1 package rows20241018_027de5ea-5c07-4960-8a98-8cf2c0e54a92.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 9 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid SoftgelDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d64f5c2-dfa9-e5f5-e063-6294a90a07112025-03-19WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLHarris Teeter, LLC322a71bb-fc68-4a03-8a24-20cbdbe6d91b2025-03-13WarningsExact identifier
application number: M010
REVASOL SLEEP AIDDIPHENHYDRAMINE HCLRnv LLC30131010-be70-c940-e063-6394a90a190a2025-03-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLL.N.K. International, Inc.1a7189ba-2d52-44fc-83a4-b9f6156c62ff2025-03-07WarningsExact identifier
application number: M010
meijer NIGHTTIME Sleep Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bede4cd-bf55-8b84-e063-6394a90aa5c92025-02-19WarningsExact identifier
application number: M010
PHARBEDRYLDIPHENHYDRAMINE HCL 50MGUlai Health LLC135293fb-5674-4638-be55-b968cf51257e2025-01-20WarningsExact identifier
application number: M010
Allergy Relief 25 mgDIPHENHYDRAMINE HCL 25MGUlai Health LLC751f13d4-c4d6-47a5-b40d-1563de08c0482025-01-12WarningsExact identifier
application number: M010
RoboCoughDEXTROMETHORPHAN HBRDXM Pharmacuetical, Inc.32fa7a09-8624-44c1-b9e4-8a8f0594292b2025-01-10WarningsExact identifier
application number: M010
SleepAid (Diphenhydramine HCL)DIPHENHYDRAMINE HCLAPNAR PHARMA LPfaaf5d51-d81d-3acc-e053-6294a90ae08f2025-01-09WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.971515fa-b4d2-1197-e053-2995a90a838d2025-01-03WarningsExact identifier
application number: M010
Nighttime Sleep-Aid SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC8b0fa259-6702-4667-bac6-f7d0b0839ae02025-01-01WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC9f1c078d-e537-4ec0-8ae9-54c98282be292024-12-31WarningsExact identifier
application number: M010
Discount Drugmart Nighttime Sleep-AidDIPHENHYDRAMINE HCLDiscount Drug Mart, Incd6d77c2e-42b3-48f0-a662-3872155ef34d2024-12-18WarningsExact identifier
application number: M010
Kroger Nighttime Sleep-AidDIPHENHYDRAMINE HCLTHE KROGER CO98437a72-1b98-4301-b92f-0c17b305cf592024-12-18WarningsExact identifier
application number: M010
equate nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.6e162152-b414-470c-b146-649d998705772024-12-17WarningsExact identifier
application number: M010
Quality Choice Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association, Inc.e8b2858b-a737-c500-e053-2995a90adba62024-12-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.f99cc210-b946-42a2-9164-8aa5308c54182024-12-11WarningsExact identifier
application number: M010
CalmCo Sleep Aid Gummy BiteDIPHENHYDRAMINE HCLCalmCo LLC0c534cbd-40e6-8af0-e063-6394a90a56052024-12-07WarningsExact identifier
application number: M010
Somnapure Clinical StrengthDIPHENHYDRAMINE HYDROCHLORIDEForce Factor Brands LLC063517c0-bcb1-46dd-85f1-bbb2f24274ef2024-12-06WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.c280cf02-ebb2-4847-a66d-d02aff3ea0c92024-12-02WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN027de5ea-5c07-4960-8a98-8cf2c0e54a923
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD027de5ea-5c07-4960-8a98-8cf2c0e54a923
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY027de5ea-5c07-4960-8a98-8cf2c0e54a923
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY027de5ea-5c07-4960-8a98-8cf2c0e54a923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-186-4072288018640355 mL in 1 BOTTLE (72288-186-40) 355 ml2021-08-060000-00-00NoNoCurrent