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 98 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-564f-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 320 CTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c596-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e20c57-7b30-4e96-e053-2991aa0aab3e2025-12-31WarningsExact identifier
application number: M020
Sun Shades Lip Balm Pina ColadaAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.16d0d2d2-b9c4-4491-8d8a-815843d342e82025-12-31WarningsExact identifier
application number: M020
Sun Shades Lip Balm Mountain MintAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.326d9623-0e67-43bd-83f8-ee7dfa3bdbe82025-12-31WarningsExact identifier
application number: M020
Sun Shades Lip Balm Vanilla BeanAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.2037cc9d-b11b-47d6-8d65-c0f9decc8ba72025-12-31WarningsExact identifier
application number: M020
Sun Shades Mineral Plus Sunscreen with Zinc OxideOCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%Melaleuca Inc.8886cbd0-ed2b-4a2b-a724-a0d4f12296c92025-12-31WarningsExact identifier
application number: M020
Eucerin Daily HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc798cbf7f-b93d-49c8-b1c1-216486e57ea52025-12-31WarningsExact identifier
application number: M020
Eucerin Face immersive HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Incfe0b3717-f472-3a61-e053-6394a90a44fb2025-12-31WarningsExact identifier
application number: M020
NIVEA MEN Age Defense Face MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc27cbec3e-e811-6498-e063-6394a90ada492025-12-31WarningsExact identifier
application number: M020
Nivea Men Maximum Hydration FaceAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf1276b11-6683-e982-e053-2a95a90a78032025-12-31WarningsExact identifier
application number: M020
Nivea Men Sensitive ProtectiveAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf6cff3d1-cca5-4b3e-a481-0c4def90684c2025-12-31WarningsExact identifier
application number: M020
Nivea Smoothness Lip CareAVOBENZONE,OCTOCRYLENEBeiersdorf Incc28e327d-ad39-9bd6-e053-2a95a90a04eb2025-12-31WarningsExact identifier
application number: M020
BOTANICAL SOOTHING SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC00a923fe-e6da-420e-a705-4773ecc2176b2025-12-31WarningsExact identifier
application number: M020
AROMA MATTE DAY SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCf822f3ec-3c57-100a-e053-6294a90ab0ec2025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC8ac09149-f7e7-40a8-b306-98964d0cd6e32025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCe389b2bc-bb1c-443a-9bf6-c6d96380f3782025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC61b6dab9-3378-4206-bf1f-6f385a9c882c2025-12-31WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d78048-d281-1d80-e063-6394a90aec192025-12-31WarningsExact identifier
application number: M020
DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INCdf535004-c94c-4a28-ad20-78bd1741e39f2025-12-31WarningsExact 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