FDA.reportPublic FDA data

NDC 41167-0014-00 - Unisom SleepMelts Nighttime Sleep-Aid

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
41167-0014
Requested NDC
41167-0014-00
Package NDCs from labels
41167-0014-0, 41167-0014-1, 41167-0014-00
Manufacturer
Chattem, Inc.
Effective date
2026-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Unisom SleepMelts Nighttime Sleep-AidChattem, Inc.2026-01-14HUMAN OTC DRUG LABEL

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 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 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

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 61 · 1,216 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
unii: TC2D6JAD40
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
application number: M010
unii: TC2D6JAD40
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: TC2D6JAD40
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
unii: TC2D6JAD40
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
application number: M010
unii: TC2D6JAD40
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationedfe32b5-9213-4350-9508-2530ee26c5d52026-09-02WarningsExact identifier
application number: M010
unii: TC2D6JAD40
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
application number: M010
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: TC2D6JAD40
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsExact identifier
application number: M010
unii: TC2D6JAD40
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsExact identifier
unii: TC2D6JAD40
MAX ALLERGY KIDSDIPHENHYDRAMINE HCLAkron Pharma Inc.96c4ade8-67b1-41e5-8624-fb49090208af2026-09-01WarningsExact identifier
unii: TC2D6JAD40
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)923b443d-73cc-4c52-92e4-a075786b1ae32026-09-01WarningsExact identifier
unii: TC2D6JAD40
ACETAMINOPHEN PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC99a137d6-07eb-43bc-b4b4-1a23041d595e2026-08-31WarningsExact identifier
unii: TC2D6JAD40
Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEHyVee Inc53157137-b980-45d2-aa10-8c111c0ec2f42026-08-31WarningsExact identifier
unii: TC2D6JAD40
acetaminophen pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSam's West Inccff9a730-2241-4e4c-bf6b-a2fa895e24172026-08-31WarningsExact identifier
unii: TC2D6JAD40
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
unii: TC2D6JAD40
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLC69af44c2-390c-4223-889a-d5555aef57782026-08-28WarningsExact identifier
unii: TC2D6JAD40
Wal Som Nighttime Sleep Aid NighttimeDIPHENHYDRAMINE HCLWalgreens4cb0f9ab-1be1-4b41-a233-bbd0327036e22026-08-28WarningsExact identifier
application number: M010
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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