FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
36800-116
11-digit product format
368000116
Labeler code
36800
Product ID
36800-116_f4be3bde-5fb8-42ec-a17b-1913624ec0da
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-116-32Nighttime Sleep Aid32 in 1 BOTTLE, PLASTICCAPSULE326
36800-116-32Nighttime Sleep Aid1 in 1 BOXCAPSULE16
36800-116-64Nighttime Sleep Aid64 in 1 BOTTLE, PLASTICCAPSULE646
36800-116-64Nighttime Sleep Aid1 in 1 BOXCAPSULE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-116NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]5Current NDC, Legacy NDC, 4 package rows20240619_027d7eff-6c83-40f1-9716-231637cdbeba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN027d7eff-6c83-40f1-9716-231637cdbeba6
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD027d7eff-6c83-40f1-9716-231637cdbeba6
1020477diphenhydramine HCl 50 MG Oral CapsuleSY027d7eff-6c83-40f1-9716-231637cdbeba6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-116-32368000116321 BOTTLE, PLASTIC in 1 BOX (36800-116-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2020-01-310000-00-00NoNoCurrent
36800-116-64368000116641 BOTTLE, PLASTIC in 1 BOX (36800-116-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC2020-01-310000-00-00NoNoCurrent