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_93c2d6bd-94aa-4b89-93f4-07f7e7c1fe11
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chattem, Inc.
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-01-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41167-0061IInactivated by FDA2026-10-05
excluded packagepackage41167-006141167-0061-0IInactivated by FDA2026-10-05
excluded packagepackage41167-006141167-0061-1IInactivated by FDA2026-10-05
excluded packagepackage41167-006141167-0061-2IInactivated by FDA2026-10-05
excluded packagepackage41167-006141167-0061-3IInactivated by FDA2026-10-05
excluded packagepackage41167-006141167-0061-5IInactivated by FDA2026-10-05
excluded packagepackage41167-006141167-0061-6IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.]8Legacy 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