Unisom SleepMelts Nighttime Sleep-Aid

Product NDC
41167-0014
11-digit product format
411670014
Labeler code
41167
Product ID
41167-0014_8cc87722-774c-4126-8c1c-9ff7841a67cd
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Chattem, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
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 SleepMelts 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
Rxcui1093098, 1093102

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
41167-0014-0Unisom SleepMelts Nighttime Sleep-Aid3 in 1 CARTONTABLET, CHEWABLE310
41167-0014-0Unisom SleepMelts Nighttime Sleep-Aid8 in 1 BLISTER PACKTABLET, CHEWABLE810
41167-0014-1Unisom SleepMelts Nighttime Sleep-Aid4 in 1 CARTONTABLET, CHEWABLE410
41167-0014-1Unisom SleepMelts Nighttime Sleep-Aid8 in 1 BLISTER PACKTABLET, CHEWABLE810

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MUNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UUNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPUNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BUNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PUNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AUNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EUNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJUNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0014UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]9Current NDC, Legacy NDC, 4 package rows20241020_9105f4f1-7f94-408d-a025-83afb68dc9f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093098diphenhydrAMINE HCl 25 MG Disintegrating Oral TabletPSN9105f4f1-7f94-408d-a025-83afb68dc9f010
1093102Unisom SleepMelts 25 MG Disintegrating Oral TabletPSN9105f4f1-7f94-408d-a025-83afb68dc9f010
1093102diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet [Unisom Sleep]SBD9105f4f1-7f94-408d-a025-83afb68dc9f010
1093098diphenhydramine hydrochloride 25 MG Disintegrating Oral TabletSCD9105f4f1-7f94-408d-a025-83afb68dc9f010
1093102Unisom Sleep 25 MG Disintegrating Oral TabletSY9105f4f1-7f94-408d-a025-83afb68dc9f010
1093102Unisom SleepMelts 25 MG Disintegrating Oral TabletSY9105f4f1-7f94-408d-a025-83afb68dc9f010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0014-0411670014003 BLISTER PACK in 1 CARTON (41167-0014-0) / 8 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2008-01-010000-00-00NoNoCurrent
41167-0014-1411670014014 BLISTER PACK in 1 CARTON (41167-0014-1) > 8 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2008-01-010000-00-00NoNoCurrent