FDA.reportPublic FDA data

Tylenol Precise Cooling Pain Relieving

Product NDC
69968-0793
11-digit product format
699680793
Labeler code
69968
Product ID
69968-0793_4aeeae88-3c06-e83e-e063-6294a90aab70
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-03
Substance
MENTHOL, UNSPECIFIED FORM; LIDOCAINE
Active strength
10; 40 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 Cooling Pain Relieving
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM10 mg/g
LIDOCAINE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
250912Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc0a3404-b174-3952-e053-6294a90a1e02Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
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84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
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9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0793-1Tylenol Precise Cooling Pain Relieving14.2 g in 1 TUBECREAM14.25
69968-0793-1Tylenol Precise Cooling Pain Relieving1 in 1 CARTONCREAM15
69968-0793-2Tylenol Precise Cooling Pain Relieving1 in 1 CARTONCREAM15
69968-0793-2Tylenol Precise Cooling Pain Relieving70 g in 1 TUBECREAM705
69968-0793-4Tylenol Precise Cooling Pain Relieving113 g in 1 TUBECREAM1135
69968-0793-4Tylenol Precise Cooling Pain Relieving1 in 1 CARTONCREAM15
69968-0793-9Tylenol Precise Cooling Pain Relieving113 g in 1 TUBECREAM1135
69968-0793-9Tylenol Precise Cooling Pain Relieving2 in 1 CARTONCREAM25
69968-0793-1TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief1 in 1 CARTONCREAM40 mg in 1g1
69968-0793-1TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief14.2 g in 1 TUBECREAM14.2 g40 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0793TYLENOL PRECISE COOLING PAIN RELIEVING (LIDOCAINE, MENTHOL) CREAM [KENVUE BRANDS LLC]4Current NDC, 8 package rows20250303_fc0a3404-b174-3952-e053-6294a90a1e02.zip
69968-0793TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF (ACETAMINOPHEN, LIDOCAINE, MENTHOL) KIT [KENVUE BRANDS LLC]1Current NDC20241204_2611e984-0dd5-bda1-e063-6394a90a559a.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 63 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4x Medicated Toothache and Gum CreamBENZOCAINEKrogera8c5090a-24f9-4e73-e053-2a95a90acca02025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINECVS0a5a8cd0-d680-8a0f-e063-6294a90aa65c2025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINEWalgreense816f742-fba9-3c12-e053-2a95a90a192f2025-11-14WarningsExact identifier
application number: M017
4x Medicated Toothache and Gum CreamBENZOCAINEWalgreensa71c2092-4ece-b82e-e053-2995a90ac9332025-11-14WarningsExact identifier
application number: M017
After Bite OutdoorDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands22b891a9-6386-dee1-e063-6394a90a5c2f2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434cb8b2-a996-5360-e063-6394a90ada032025-11-13WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED4360e3ec-7a4b-b28e-e063-6294a90a0bd62025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED4360e3be-0ec4-cd57-e063-6394a90aca632025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED43616ad7-58bb-e5ad-e063-6394a90a192b2025-11-13WarningsExact identifier
application number: M017
4x Medicated Severe Toothache and Gum GelBENZALKONIUM CHLORIDEMeijer97ce7890-5093-1763-e053-2a95a90afae72025-11-13WarningsExact identifier
application number: M017
Pain RelieverCAMPHOR, MENTHOLKool 'N Fit Inc.2253f6bd-5707-b993-e063-6394a90aa74a2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED4360e0d1-46cd-ab4b-e063-6394a90a55e12025-11-12WarningsExact identifier
application number: M017
CVS Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECVS8723e097-296f-784a-e053-2991aa0a552e2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154d8821-3e76-b0e2-e063-6294a90ae0772025-11-12WarningsExact identifier
application number: M017
Good neighbor Pharmacy Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEAMERISOURCEBERGEN DRUG CORPORATION87395273-380c-7cef-e053-2991aa0a54c62025-11-12WarningsExact identifier
application number: M017
Quality Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEChain Drug Marketing Association8735b298-83f3-0b5d-e053-2a91aa0a82922025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.1550e794-b3c0-4769-e063-6294a90a8c2d2025-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250912lidocaine 4 % / menthol 1 % Topical CreamPSNfc0a3404-b174-3952-e053-6294a90a1e025
250912lidocaine 40 MG/ML / menthol 10 MG/ML Topical CreamSCDfc0a3404-b174-3952-e053-6294a90a1e025
250912lidocaine 4 % / menthol 1 % Topical CreamSYfc0a3404-b174-3952-e053-6294a90a1e025
198440acetaminophen 500 MG Oral TabletPSN2611e984-0dd5-bda1-e063-6394a90a559a1
250912lidocaine 4 % / menthol 1 % Topical CreamPSN2611e984-0dd5-bda1-e063-6394a90a559a1
209459Tylenol Extra Strength 500 MG Oral TabletPSN2611e984-0dd5-bda1-e063-6394a90a559a1
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD2611e984-0dd5-bda1-e063-6394a90a559a1
198440acetaminophen 500 MG Oral TabletSCD2611e984-0dd5-bda1-e063-6394a90a559a1
250912lidocaine 40 MG/ML / menthol 10 MG/ML Topical CreamSCD2611e984-0dd5-bda1-e063-6394a90a559a1
198440APAP 500 MG Oral TabletSY2611e984-0dd5-bda1-e063-6394a90a559a1
209459APAP 500 MG Oral Tablet [Tylenol]SY2611e984-0dd5-bda1-e063-6394a90a559a1
250912lidocaine 4 % / menthol 1 % Topical CreamSY2611e984-0dd5-bda1-e063-6394a90a559a1
209459Tylenol 500 MG Oral TabletSY2611e984-0dd5-bda1-e063-6394a90a559a1
209459Tylenol Extra Strength 500 MG Oral TabletSY2611e984-0dd5-bda1-e063-6394a90a559a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0793-1699680793011 TUBE in 1 CARTON (69968-0793-1) / 14.2 g in 1 TUBE1 tube2023-07-03NoNoCurrent
69968-0793-2699680793021 TUBE in 1 CARTON (69968-0793-2) / 70 g in 1 TUBE1 tube2025-11-30NoNoCurrent
69968-0793-4699680793041 TUBE in 1 CARTON (69968-0793-4) / 113 g in 1 TUBE1 tube2023-07-03NoNoCurrent
69968-0793-9699680793092 TUBE in 1 CARTON (69968-0793-9) / 113 g in 1 TUBE2 tube2024-03-01NoNoCurrent