FDA.reportPublic FDA data

Unisom SleepMelts Nighttime Sleep-Aid

Product NDC
41167-0014
Requested package NDC
41167-0014-0
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

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1093098Internal RxNorm lookup
1093102Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9105f4f1-7f94-408d-a025-83afb68dc9f0Available on FDA.report

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

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
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
application number: M010
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationedfe32b5-9213-4350-9508-2530ee26c5d52026-09-02WarningsExact identifier
application number: M010
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
application number: M010
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsExact identifier
application number: M010
Wal Som Nighttime Sleep Aid NighttimeDIPHENHYDRAMINE HCLWalgreens4cb0f9ab-1be1-4b41-a233-bbd0327036e22026-08-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsExact identifier
application number: M010
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEHyVee Inc496ce4ba-08a9-ee99-e063-6294a90ac9a72026-08-21WarningsExact identifier
application number: M010
CVS Nighttime Childrens Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACYd66b1a2e-49b6-473b-acec-2694c73ce8b42026-08-19WarningsExact identifier
application number: M010
CVS Childrens Nighttime Multi Symptom ColdACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d2026-08-19WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsExact identifier
application number: M010
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsExact identifier
application number: M010
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

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