FDA.reportPublic FDA data

CVS Health Sunburn Relief Cooling

Product NDC
51316-066
11-digit product format
513160066
Labeler code
51316
Product ID
51316-066_1d63d6e4-81ec-0a41-e063-6394a90ae83e
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
CVS PHARMACY
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-31
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
5 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
CVS Health Sunburn Relief Cooling
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010931Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d6402ea-4201-27f9-e063-6294a90a43f5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-066-25CVS Health Sunburn Relief Cooling170 g in 1 CANSPRAY1701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-066CVS HEALTH SUNBURN RELIEF COOLING (LIDOCAINE HYDROCHLORIDE) SPRAY [CVS PHARMACY]1Current NDC, 1 package rows20240718_1d6402ea-4201-27f9-e063-6294a90a43f5.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 106 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC85f3dd47-4f1f-4fa3-a171-4f4b7707191c2025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC4e5764f3-9d9e-460b-ab1e-36f280281dec2025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUMTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe700dc6e-e7ae-47ee-9974-430bfd045b4f2025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCc7924d60-03fb-4a4d-b718-e324f6f1f65f2025-12-19WarningsExact identifier
application number: M020
THE GOLDEN GUARD Browning Radiance Gel Suncare for BodyAVOBENZONE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.4654c417-faa3-23c6-e063-6394a90a2b5a2025-12-19WarningsExact identifier
application number: M020
THE MINERAL MELT Invisible Mineral Suncare for FaceTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.46557319-7546-e712-e063-6394a90a3cfe2025-12-19WarningsExact identifier
application number: M020
Sand Cloud Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff477199-9b01-fc90-e053-6294a90a51022025-12-19WarningsExact identifier
application number: M020
Sand Cloud Mineral Sunscreen For FaceTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff2346c6-d911-87b3-e053-6394a90ac6f82025-12-19WarningsExact identifier
application number: M020
Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - ShellTITANIUM DIOXIDE, ZINC OXIDERodan & Fields12c63195-8707-4df0-a4d3-6f31c543db7a2025-12-19WarningsExact identifier
application number: M020
EltaMD UV SPF35OCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc3029d6ed-a60b-4789-a567-d09b12d76bf42025-12-19WarningsExact identifier
application number: M020
OUHOE Universal Colored MoisturizerTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4634fdcd-6f0e-25ca-e063-6294a90a196e2025-12-18WarningsExact identifier
application number: M020
SUNSCREEN SPRAY150mLZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4635f90a-bbc9-0676-e063-6394a90a9f352025-12-18WarningsExact identifier
application number: M020
Sunscreen StickHOMOSALATE 15%, OCTISALLATE 5%, ENSULIZOLE 4%Foshan Sugar Max Cosmetics CO.,Ltd4637503c-46dc-68de-e063-6394a90abdc72025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe78c9ae0-c2ef-12ce-e053-2995a90abf1c2025-12-18WarningsExact identifier
application number: M020
NARS PURE RADIANT TINTED MOISTURIZER CuzcoOCTINOXATE, TITANIUM DIOXIDENARS Cosmetics5bb5d035-16d9-4843-b9aa-d30730c885082025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Micro-Sculpting Hydrating Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company248be719-edff-f40d-e063-6394a90a4ef62025-12-18WarningsExact identifier
application number: M020
Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company59187729-c166-58fe-e053-2991aa0abe472025-12-18WarningsExact identifier
application number: M020
GM Collin SPF 25 UVA - UVB Urban Protection Veil SunscreenZINC OXIDE AND TITANIUM DIOXIDELaboratoires Dermo-Cosmetik Inc.4f0d44ca-09f0-4feb-b78c-77d83e75d4e22025-12-18WarningsExact identifier
application number: M020
Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company60a304b1-eee5-408b-e053-2a91aa0a0a082025-12-18WarningsExact identifier
application number: M020
THE BOD GUARD Invisible Gel Sunscreen for BodyAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.463fa1ef-d40d-d818-e063-6294a90a5e612025-12-18WarningsExact identifier
application number: M020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010931lidocaine HCl 0.5 % Topical SprayPSN1d6402ea-4201-27f9-e063-6294a90a43f51
1010931lidocaine hydrochloride 5 MG/ML Topical SpraySCD1d6402ea-4201-27f9-e063-6294a90a43f51
1010931lidocaine hydrochloride 0.5 % Topical SpraySY1d6402ea-4201-27f9-e063-6294a90a43f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-066-2551316006625170 g in 1 CAN (51316-066-25) 170 g2023-10-31NoNoCurrent