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 65 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Mineral Sunscreen SPF 30ZINC OXIDETanning Club LLCd674ccbc-7bae-435c-a531-a79e569e69a92026-02-04WarningsExact identifier
application number: M020
Derma B Everyday Fit Sunscreen SPF 50AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeoPharm Co., Ltd.ba38a43d-7a8a-4814-ba34-0e99124f5fca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION42adc51f-f500-485d-82a0-1266721412622026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION60e55ebb-47b8-465e-819a-af195952e1ca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE NUTRIPERFECT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf644c67b-3a71-411b-b321-39a8b18af0c72026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation4b242b76-8aed-4939-9906-741828acd8152026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationefcf240f-95cb-45e0-b58a-9c8f3609aa552026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation270ecc83-4262-4102-a753-2acaf11360a02026-02-04WarningsExact identifier
application number: M020
Walgreens 50 Caramel and Pistachio Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4a038017-9f15-b4b2-e063-6294a90a1b232026-02-04WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationce6a28c1-56e6-4105-bc9d-9d1986ead4202026-02-04WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd52e2c61-edbc-4c26-b1a7-e8eb656db1882026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd365ed6d-a92f-473b-be19-b8b63d17f3b72026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETER0a3b4597-06fe-4689-9751-6577867d755e2026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERb83ea476-fa32-4405-9ae3-f294836edb622026-02-04WarningsExact identifier
application number: M020
Sunplus SPF50 Face Body SunscreenSUNSCREENI.Shay Cosmetics26d55baf-66dc-b1b8-e063-6394a90a670d2026-02-04WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel GlowZINC OXIDE SUNSCREENBentley Laboratories, LLC351217c4-8d71-41d9-ab08-c43857c0510c2026-02-04WarningsExact identifier
application number: M020
NIDA Invisible Fit Sun StickSUN STICKProso Corp49eca4f2-aae3-a0d5-e063-6394a90ab25f2026-02-03WarningsExact identifier
application number: M020
Shiny Hiny SPF 45 Mineral SunscreenZINC OXIDEShiny Hiny Products, LLC31adde36-5e1b-40ff-e063-6294a90a6f2e2026-02-03WarningsExact identifier
application number: M020
Walgreens 50 Passion Fruit Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49f030d8-959c-a3cd-e063-6294a90ae1ba2026-02-03WarningsExact 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