FDA.reportPublic FDA data

Unisom SleepMinis Nighttime Sleep-Aid

Product NDC
41167-0067
11-digit product format
411670067
Labeler code
41167
Product ID
41167-0067_2bf9a980-5845-44ff-aad4-1dbcfd67f6eb
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Chattem, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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

Additional Listing Data#

Finished product
Yes
Brand name base
Unisom SleepMinis Nighttime Sleep-Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909, 1648369

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
41167-0067-0Unisom SleepMinis Nighttime Sleep-Aid1 in 1 CARTONCAPSULE18
41167-0067-0Unisom SleepMinis Nighttime Sleep-Aid60 in 1 BOTTLE, PLASTICCAPSULE608
41167-0067-2Unisom SleepMinis Nighttime Sleep-Aid1 in 1 CARTONCAPSULE18
41167-0067-2Unisom SleepMinis Nighttime Sleep-Aid20 in 1 BOTTLE, PLASTICCAPSULE208

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MUNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDUNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYUNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LUNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GUNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HUNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJUNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0067UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]7Current NDC, Legacy NDC, 4 package rows20231012_a9a44c2f-65eb-4a5a-9e72-43652dce57f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNa9a44c2f-65eb-4a5a-9e72-43652dce57f78
1648369Unisom SleepMinis 25 MG Oral CapsulePSNa9a44c2f-65eb-4a5a-9e72-43652dce57f78
1648369diphenhydramine hydrochloride 25 MG Oral Capsule [Unisom Sleep]SBDa9a44c2f-65eb-4a5a-9e72-43652dce57f78
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDa9a44c2f-65eb-4a5a-9e72-43652dce57f78
1648369Unisom Sleep 25 MG Oral CapsuleSYa9a44c2f-65eb-4a5a-9e72-43652dce57f78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41167-0067-0411670067001 BOTTLE, PLASTIC in 1 CARTON (41167-0067-0) / 60 CAPSULE in 1 BOTTLE, PLASTIC2015-04-010000-00-00NoNoCurrent
41167-0067-2411670067021 BOTTLE, PLASTIC in 1 CARTON (41167-0067-2) > 20 CAPSULE in 1 BOTTLE, PLASTIC2015-04-010000-00-00NoNoCurrent