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 173 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
application number: M020
Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDETHG Beauty USA LLC1cd10158-c346-60c9-e063-6294a90a54bd2025-10-29WarningsExact identifier
application number: M020
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
application number: M020
Hello Bello Kids Mineral SunscreenZINC OXIDE TITANIUM OXIDEHello Bello3e7a3e8e-eacf-0a30-e063-6294a90ab7ec2025-10-29WarningsExact identifier
application number: M020
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23f4cf41-0eed-2df3-e063-6294a90ad4022025-10-28WarningsExact identifier
application number: M020
goPure SunscreenZINC OXIDENatural Lifestyle Brands, LLC dba GoPure beautya74ec20b-8436-4030-820c-01fd88134f402025-10-27WarningsExact identifier
application number: M020
KidsBliss Baby and Kids Mineral Sunscreen SPF50ZINC OXIDEVeganicSKN2dfa236f-128b-17bb-e063-6294a90aa29c2025-10-24WarningsExact identifier
application number: M020
Oze Sun Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd7477-445f-d1d5-e063-6394a90a46072025-10-24WarningsExact identifier
application number: M020
Oze Sun reef safe Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd936b-0ea6-03a2-e063-6394a90a4fba2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 yearsZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de1cd7-fdfd-7f7a-e063-6394a90a9b5c2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 7 years to adultZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de09dc-544f-9780-e063-6394a90acd272025-10-24WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC23670a30-6619-0651-e063-6394a90af9782025-10-24WarningsExact identifier
application number: M020
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30TITANIUM DIOXIDETHG Beauty USA LLC397b4338-fec8-5228-e063-6394a90ad97d2025-10-23WarningsExact identifier
application number: M020
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDETHG Beauty USA LLC38c80373-1d5a-c7f4-e063-6294a90aa9c22025-10-23WarningsExact identifier
application number: M020
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35ZINC OXIDE, TITANIUM DIOXIDETHG Beauty USA LLC254b4692-a459-6119-e063-6394a90a0a602025-10-23WarningsExact identifier
application number: M020
AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENECHOP SAVER FRESH CITRUS SPF 15 LIP BALMGood for the Goose Products, LLC2786cec8-0b8e-9c83-e063-6394a90ab3382025-10-23WarningsExact identifier
application number: M020
Calendula Essential Hydrating Broad Spectrum SPF 30 SunscreenZINC OXIDENaturopathica Holistic Health41d75815-e281-bf88-e063-6294a90afeff2025-10-23WarningsExact identifier
application number: M020
Thrive Daily Sunscreen For Sensitive Skin SPF 30ZINC OXIDEThrive Natural Care, Inc128e1a3a-df40-f51c-e063-6394a90a19022025-10-23WarningsExact identifier
application number: M020
Thrive Bodyshield 50 SPF 50ZINC OXIDEThrive Natural Care, Inc12d9e1d0-c59c-f770-e063-6294a90a81912025-10-23WarningsExact identifier
application number: M020
Good Defense Daily Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEOffspring Beauty Co.2a462e60-6353-f791-e063-6294a90a62e32025-10-23WarningsExact 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