Tylenol Precise Nighttime Pain Relieving

Product NDC
69968-0905
11-digit product format
699680905
Labeler code
69968
Product ID
69968-0905_2ef4fe0e-abe6-4601-e063-6394a90a99f9
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-24
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
40; 12.5 mg/g; mg/g
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
Tylenol Precise Nighttime Pain Relieving
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)40 mg/g
MENTHOL12.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2604039Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ef4fe16-0820-6aad-e063-6294a90a8449Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0905-4Tylenol Precise Nighttime Pain Relieving1 in 1 CARTONCREAM11
69968-0905-4Tylenol Precise Nighttime Pain Relieving113 g in 1 TUBECREAM1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0905TYLENOL PRECISE NIGHTTIME PAIN RELIEVING (CAMPHOR, MENTHOL) CREAM [KENVUE BRANDS LLC]1Current NDC, 2 package rows20250325_2ef4fe16-0820-6aad-e063-6294a90a8449.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 42 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cortizone 10 Fast Acting Itch Relief CoolingHYDROCORTISONEChattem, Inc.01cd77e3-380f-4487-ae6e-3ac45355d8a42026-01-14WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd0174411c-1b10-4298-b820-87b24065b1182026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing for EczemaHYDROCORTISONEChattem, Inc.31dc0f1f-ddd8-41dc-b669-b24655634d552026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Overnight CremeHYDROCORTISONEChattem, Inc.ef2eda7e-d6a8-47e3-9d80-6074af6773dc2026-01-14WarningsExact identifier
application number: M017
CVS Pain Relief Lavender ScentMENTHOL 4%CVS484b0833-9f8a-f155-e063-6294a90a18692026-01-13WarningsExact identifier
application number: M017
EARTHS CARE ANTI-ITCHCAMPHOR (NATURAL), MENTHOLDLC Laboratories, Inc.d1eabb5f-7086-4ff0-a398-3703c9ecd4412026-01-13WarningsExact identifier
application number: M017
HealthWise Cold Therapy Menthol Pain ReliefMENTHOLVeridian Healthcare25e3d9cd-6ba3-4e06-8853-324b9d6692482026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.1ac2ed54-194c-4de2-8e7f-6e74ca32aa402026-01-13WarningsExact identifier
application number: M017
Pain Release Joint and Arthritis CreamMENTHOLSaje Natural Business Inc.18b24d75-17f7-1a35-e063-6394a90a55e02026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.a32b0950-3467-4e37-988d-104836af59712026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.92eec6e7-0367-43c6-bd28-1762390a71142026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.481a493b-0620-46ac-8228-e9964b7eb24b2026-01-13WarningsExact identifier
application number: M017
RestoralMENTHOLSaje Natural Business Inc.5b6176c1-9ed9-1950-e053-2a91aa0a434e2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Eucalyptus Essential OilLIDOCAINE HCLChattem, Inc.03e247b4-a2e2-4354-a018-880f1bc987fd2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine Foot (Diabetic)LIDOCAINE HYDROCHLORIDEChattem, Inc.2c33d15e-5032-46d9-bd98-5abc7df3bbe52026-01-13WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Essential Oils Rosemary MintLIDOCAINEChattem, Inc.9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab2026-01-13WarningsExact identifier
application number: M017
Capzasin HP Arthritis Pain ReliefCAPSAICINChattem, Inc.345c9159-0efe-436b-9068-3b717678936b2026-01-13WarningsExact identifier
application number: M017
Capzasin Quick ReliefCAPSAICIN AND MENTHOLChattem, Inc.d6c313a3-8dc6-4231-95b6-ac9399e1c1be2026-01-13WarningsExact identifier
application number: M017
Aspercreme Pain RelievingTROLAMINE SALICYLATEChattem, Inc.97dd587b-ecc3-4b4b-a116-6355d3c6ea6d2026-01-13WarningsExact identifier
application number: M017
Dr Wellskin Numbing Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD482f25cc-dee3-c3b6-e063-6294a90a86742026-01-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604039camphor 4 % / menthol 1.25 % Topical CreamPSN2ef4fe16-0820-6aad-e063-6294a90a84491
2604039camphor 40 MG/ML / menthol 12.5 MG/ML Topical CreamSCD2ef4fe16-0820-6aad-e063-6294a90a84491
2604039camphor 4 % / menthol 1.25 % Topical CreamSY2ef4fe16-0820-6aad-e063-6294a90a84491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0905-4699680905041 TUBE in 1 CARTON (69968-0905-4) / 113 g in 1 TUBE1 tube2025-03-24NoNoCurrent