Home NDC 69968-0905 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 Ingredient Strength CAMPHOR (SYNTHETIC) 40 mg/g MENTHOL 12.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TJD82A1ET Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2604039 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69968-0905-4 Tylenol Precise Nighttime Pain Relieving 1 in 1 CARTON CREAM 1 1 69968-0905-4 Tylenol Precise Nighttime Pain Relieving 113 g in 1 TUBE CREAM 113 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0905 TYLENOL PRECISE NIGHTTIME PAIN RELIEVING (CAMPHOR, MENTHOL) CREAM [KENVUE BRANDS LLC] 1 Current NDC, 2 package rows 20250325_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 94 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dollar General Cold-Hot Medicated Patches MENTHOL DOLGENCORP, LLC e13ab4d3-eb58-4874-925a-6a59df4dd29a 2025-04-14 Warnings Exact identifier application number: M017 AY BENDITO - PAIN RELIEF CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC b97f6b71-7de7-3217-e053-2a95a90aa426 2025-04-14 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC bbf0d85e-269d-0342-e053-2995a90ac63c 2025-04-14 Warnings Exact identifier application number: M017 Biofreeze Menthol MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC 71a36691-9d9e-479d-bfdc-6f6b192ad2d0 2025-04-11 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Borden Company (Private) Limited da3358ae-8679-6045-e053-2a95a90a50e3 2025-04-10 Warnings Exact identifier application number: M017 Jointflex JOINTFLEX Strides Consumer LLC b82ec69c-bd00-400b-bd94-ac15fb620f9b 2025-04-09 Warnings Exact identifier application number: M017 Zepol Topical Analgesic CAMPHOR, MENTHOL Laboratorios Zepol S.A. ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9 2025-04-09 Warnings Exact identifier application number: M017 Jointflex CAMPHOR Strides Consumer LLC cb5ca02b-0bc1-4b0b-b4b1-abef3222aa56 2025-04-09 Warnings Exact identifier application number: M017 Foster and Thrive Lidocaine Pain Relief Patch LIDOCAINE 4% Strategic Sourcing Services LLC 32456887-aa09-8912-e063-6394a90a4ae7 2025-04-08 Warnings Exact identifier application number: M017 MUSCLE MENTHOL WATER-JEL TECHNOLOGIES 1af399af-07b0-4899-9bcc-1e244b63b1cf 2025-04-08 Warnings Exact identifier application number: M017 Lidocaine with Menthol LIDOCAINE HCL AND MENTHOL Kareway Product, Inc. 9ee46a5b-d00c-4254-e053-2995a90aeb3a 2025-04-08 Warnings Exact identifier application number: M017 Foster and Thrive Lidocaine Pain Relief Patch LIDOCAINE 4% Strategic Sourcing Services LLC 324802c9-e2c2-bf74-e063-6394a90a8697 2025-04-08 Warnings Exact identifier application number: M017 OARS AND ALPS MUSCLE RECOVERY BALM MENTHOL, METHYL SALICYLATE Cosco International, Inc 8745802f-018d-4cf8-bbf3-3b04c8f54538 2025-04-08 Warnings Exact identifier application number: M017 NOVUM APR MENTHOL NOVUM SOLUTIONS INC 1b869a1f-5787-4d03-a546-43a8217b2b2c 2025-04-07 Warnings Exact identifier application number: M017 MAG 5 PT ROLL-ON PAIN RELIEF COOLING MENTHOL RENU LABORATORIES, LLC 31e4fa2c-3a98-d618-e063-6394a90aec1c 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC cc7cbf4a-8274-e463-e053-2995a90a51e0 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee018a-2c3c-3116-e053-2a95a90ac8d8 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee2b65-2759-0e62-e053-2a95a90a0378 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bdc7c7f3-ac98-8fe9-e053-2a95a90a2663 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bd4fdff1-9174-31c2-e053-2a95a90a749f 2025-04-07 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69968-0905-4 69968090504 1 TUBE in 1 CARTON (69968-0905-4) / 113 g in 1 TUBE 1 tube 2025-03-24 No No Current