FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
37808-186
11-digit product format
378080186
Labeler code
37808
Product ID
37808-186_c201060b-0500-4a9e-9e96-a1b149bf232c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-10-30
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

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Sleep Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

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
37808-186-30Nighttime Sleep Aid177 mL in 1 BOTTLESOLUTION1776
37808-186-40Nighttime Sleep Aid355 mL in 1 BOTTLESOLUTION3556

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-186NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [H E B]6Current NDC, Legacy NDC, 2 package rows20241018_d5189048-5eed-4ec4-8c4a-4a167728c4e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSNd5189048-5eed-4ec4-8c4a-4a167728c4e76
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCDd5189048-5eed-4ec4-8c4a-4a167728c4e76
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSYd5189048-5eed-4ec4-8c4a-4a167728c4e76
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSYd5189048-5eed-4ec4-8c4a-4a167728c4e76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-186-3037808018630177 mL in 1 BOTTLE (37808-186-30) 177 ml2016-04-110000-00-00NoNoCurrent
37808-186-4037808018640355 mL in 1 BOTTLE (37808-186-40) 355 ml2013-10-300000-00-00NoNoCurrent