FDA.reportPublic FDA data

Tylenol Precise Cooling Pain Relieving

Product NDC
69968-0793
Requested package NDC
69968-0793-2
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
LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
40; 10 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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
application number: M017
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
application number: M017
Auixudin Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.57bc7b9e-e2f7-724b-e063-6394a90ab36f2026-07-29WarningsExact identifier
application number: M017
Jinfahe Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.57bcd9c5-767e-b634-e063-6394a90a28782026-07-29WarningsExact identifier
application number: M017
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
application number: M017
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.57ca9220-2778-790a-e063-6294a90af5062026-07-29WarningsExact identifier
application number: M017
Aspercreme Lidocaine No-Mess plus LavenderLIDOCAINE HCLChattem, Inc.3948a3d2-ce04-4703-8709-211e75c9c38d2026-07-29WarningsExact identifier
application number: M017
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
application number: M017
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsExact identifier
application number: M017
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal CreamLIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57935b64-6e2e-85d0-e063-6394a90a74282026-07-27WarningsExact identifier
application number: M017
1% Hydrocortisone Anti-itch1% HYDROCORTISONE ANTI-ITCHALAINA HEALTHCARE PRIVATE LIMITEDb8416467-55f7-4e5f-a5cb-3abd3e2bb5772026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017

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 FORM40 mg/g
LIDOCAINE10 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
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
377068df-225f-7318-a910-a1987cdfa361Product name320170608
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
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
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
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

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
69968-0793-2699680793021 TUBE in 1 CARTON (69968-0793-2) / 70 g in 1 TUBE1 tube2025-11-30NoNoCurrent