FDA.reportPublic FDA data

Unisom SleepGels Nighttime Sleep-Aid

Product NDC
41167-0061
Requested package NDC
41167-0061-5
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41167-006141167-0061-5IInactivated by FDA2026-08-17

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 14 · 262 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENCVS PHARMACY333e170e-52cd-4218-8d15-0bf3c5c75cb92026-08-14WarningsExact identifier
application number: M010
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsExact identifier
application number: M010
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
application number: M010
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLDOLGENCORP, LLC2bb3016a-2e03-43fe-a655-45d4ec872c792026-08-05WarningsExact identifier
application number: M010
Nighttime Sleep Aid Alcohol FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inc6e398d21-6cfa-4f9b-9219-0cd949e882662026-08-05WarningsExact identifier
application number: M010
Sleep TabsDIPHENHYDRAMINE HCLMajor Pharmaceuticalsff8b7346-5be5-4e76-9ee2-d52fab66f6c52026-08-03WarningsExact identifier
application number: M010
MantraMANTRA SLEEP AID WILD CHERRYMOREMED INC.316d11fe-a173-a1dd-e063-6394a90af4992026-07-27WarningsExact identifier
application number: M010
Wal Som Nighttime Sleep AidDIPHENHYDRAMINE HCLWalgreensff475a69-dbb2-40a9-b7f4-9c7b7e975d192026-07-23WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporation336ac29d-db24-44da-a299-5a4793ae8f6a2026-07-21WarningsExact identifier
application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLBEST CHOICE (VALU MERCHANDISERS COMPANY)9bf2d698-8394-46c3-b7a9-e99ab6bb88e42026-07-17WarningsExact identifier
application number: M010
ADWE dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDERARITAN PHARMACEUTICALS INCea3a51af-3025-497f-8cd7-e99391b0d06f2026-07-17WarningsExact identifier
application number: M010
nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLCa8056e5f-e9d8-4555-9212-bf1fa3c154392026-07-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen147adc14-ca7c-45f5-9925-ea569edbfe962026-07-09WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 25 MGHealth Pharma USA LLCd659f747-9790-8bd6-e053-2995a90ae7932026-07-07WarningsExact identifier
application number: M010
PharbedrylDIPHENHYDRAMINE HCLSt. Mary's Medical Park Pharmacy3ef18965-bafb-cc19-e063-6394a90af17d2026-06-29WarningsExact identifier
application number: M010
CalmCo Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC552d0e50-a58c-8e47-e063-6394a90a8f7b2026-06-26WarningsExact identifier
application number: M010
Vicks ZzzQuil Night PainDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENThe Procter & Gamble Manufacturing Companya7cf8e2e-7aac-a1fa-e053-2a95a90a561a2026-06-26WarningsExact identifier
application number: M010

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41167-0061-5411670061051 BOTTLE, PLASTIC in 1 CARTON (41167-0061-5) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2007-01-010000-00-00NoNoCurrent