FDA.reportPublic FDA data

Unisom SleepGels Nighttime Sleep-Aid

Product NDC
41167-0061
11-digit product format
411670061
Labeler code
41167
Product ID
41167-0061_a1d6cb59-d551-4962-83d3-af033a757b63
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chattem, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477, 1093113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0061-0Unisom SleepGels Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED19
41167-0061-0Unisom SleepGels Nighttime Sleep-Aid8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED89
41167-0061-1Unisom SleepGels Nighttime Sleep-Aid8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED89
41167-0061-1Unisom SleepGels Nighttime Sleep-Aid2 in 1 CARTONCAPSULE, LIQUID FILLED29
41167-0061-2Unisom SleepGels Nighttime Sleep-Aid100 in 1 BOTTLECAPSULE, LIQUID FILLED1009
41167-0061-2Unisom SleepGels Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED19
41167-0061-3Unisom SleepGels Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED19
41167-0061-3Unisom SleepGels Nighttime Sleep-Aid32 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED329
41167-0061-5Unisom SleepGels Nighttime Sleep-Aid40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED409
41167-0061-5Unisom SleepGels Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED19
41167-0061-6Unisom SleepGels Nighttime Sleep-Aid60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED609
41167-0061-6Unisom SleepGels Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0061-3EA - Each41167-00618120fd9b-bd32-4acf-aa08-8f9b6134735412022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40UNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MUNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDUNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LUNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AUNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3UNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RUNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RUNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0061UNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]8Current NDC, Legacy NDC, 12 package rows20231012_17383d22-91cc-4d9e-a0b8-3f7d9a18af83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN17383d22-91cc-4d9e-a0b8-3f7d9a18af839
1093113Unisom SleepGels 50 MG Oral CapsulePSN17383d22-91cc-4d9e-a0b8-3f7d9a18af839
1093113diphenhydramine hydrochloride 50 MG Oral Capsule [Unisom Sleep]SBD17383d22-91cc-4d9e-a0b8-3f7d9a18af839
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD17383d22-91cc-4d9e-a0b8-3f7d9a18af839
1020477diphenhydramine HCl 50 MG Oral CapsuleSY17383d22-91cc-4d9e-a0b8-3f7d9a18af839
1093113Unisom Sleep 50 MG Oral CapsuleSY17383d22-91cc-4d9e-a0b8-3f7d9a18af839
1093113Unisom Sleepgels Maximum Strength 50 MG Oral CapsuleSY17383d22-91cc-4d9e-a0b8-3f7d9a18af839

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0061-0411670061001 BLISTER PACK in 1 CARTON (41167-0061-0) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2007-01-010000-00-00NoNoCurrent
41167-0061-1411670061012 BLISTER PACK in 1 CARTON (41167-0061-1) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2007-01-010000-00-00NoNoCurrent
41167-0061-2411670061021 BOTTLE in 1 CARTON (41167-0061-2) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-09-150000-00-00NoNoCurrent
41167-0061-3411670061031 BOTTLE, PLASTIC in 1 CARTON (41167-0061-3) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2007-01-010000-00-00NoNoCurrent
41167-0061-5411670061051 BOTTLE, PLASTIC in 1 CARTON (41167-0061-5) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2007-01-010000-00-00NoNoCurrent
41167-0061-6411670061061 BOTTLE, PLASTIC in 1 CARTON (41167-0061-6) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2007-01-010000-00-00NoNoCurrent