TopCare Everyday After Sun Cooling

Product NDC
36800-953
11-digit product format
368000953
Labeler code
36800
Product ID
36800-953_24882cf3-66aa-4a61-e063-6394a90a63b5
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
TOPCO ASSOCIATES LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-05
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
TopCare Everyday After Sun 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
1011849Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
baff7293-e1a3-d1f2-e053-2995a90a93caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-953-80TopCare Everyday After Sun Cooling226 g in 1 BOTTLEGEL2262

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-953TOPCARE EVERYDAY AFTER SUN COOLING (LIDOCAINE HYDROCHLORIDE) GEL [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 1 package rows20241017_baff7293-e1a3-d1f2-e053-2995a90a93ca.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 110 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Strength Muscle RubCAMPHOR, MENTHOL, METHYL SALICYLATEThe Mentholatum Company32b64985-0e2f-49ee-9840-946d7279fee72024-12-17WarningsExact identifier
application number: M017
CVS Health Cold and Hot Pain Relieving Extra StrengthMENTHOL, METHYL SALICYLATECVS Pharmacy1ca1a631-cb2c-46cd-bd41-05469b08d2082024-12-17WarningsExact identifier
application number: M017
Mentholatum Pain RelievingMENTHOL, METHYL SALICYLATEThe Mentholatum Company0056b952-9870-485a-9f35-f985472875a92024-12-17WarningsExact identifier
application number: M017
Mentholatum Lidocaine HeatLIDOCAINE HCLThe Mentholatum Companycc2ef25a-b569-4d48-a666-899f710b4b342024-12-17WarningsExact identifier
application number: M017
Rite Aid Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATERite Aid Corporation039fff40-b5ba-42cb-932c-8a70ca92759d2024-12-17WarningsExact identifier
application number: M017
Signature Care Cold and Hot MedicatedMENTHOLSafeway88f59f95-0a7c-458c-949c-0dff16ad94e42024-12-17WarningsExact identifier
application number: M017
Equate Cool and HeatMENTHOL, METHYL SALICYLATEWal-Mart Stores Incc5ab2426-eeca-4ba4-9f00-7790d21764712024-12-17WarningsExact identifier
application number: M017
CVS Health Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a2024-12-17WarningsExact identifier
application number: M017
DG Health Maximum Strength Pain Relieving CleansingBENZALKONIUM CL, LIDOCAINE HCLDollar General Corporation64f69315-77a3-49dc-940d-efd7a29c66452024-12-17WarningsExact identifier
application number: M017
ChiggerexBENZOCAINERANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH5e5d84ab-f57f-448d-a4c1-ced38890eec22024-12-17WarningsExact identifier
application number: M017
DerMend Moisturizing Anti-ItchPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.14c7fb1c-a310-4b12-ab2e-7f1c0801995c2024-12-17WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEGeri-Care Pharmaceuticals, Corpfd67566a-1076-019d-e053-6394a90a415c2024-12-17WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATENATURES FORMULAE HEALTH PRODUCTS LTD.d919b50a-5de2-1830-e053-2a95a90ab88d2024-12-17WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLWalgreen Company1f262473-3f3c-4f3f-b507-590d06ff69a92024-12-17WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEWalgreen Companydb8cf218-7544-4871-b1c3-a50a3d3e59f12024-12-17WarningsExact identifier
application number: M017
Albertsons Pain Relief PatchLIDOCAINESafewaydc2823bb-8586-daca-e053-2995a90a2af02024-12-17WarningsExact identifier
application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREASCAPSAICINWalgreen Companye77167ab-6cb8-4d5b-838c-b0acc05e38892024-12-17WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLWalgreen Companyd9fc133d-ebaa-48f1-a6f9-62453970012b2024-12-17WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company204b96bc-af4e-4842-8b57-7b416feb4dd92024-12-17WarningsExact identifier
application number: M017
Lidocaine DryLIDOCAINECVSbb7955fe-5113-1662-e053-2a95a90a85a12024-12-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011849lidocaine HCl 0.5 % Topical GelPSNbaff7293-e1a3-d1f2-e053-2995a90a93ca2
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCDbaff7293-e1a3-d1f2-e053-2995a90a93ca2
1011849lidocaine hydrochloride 0.5 % Topical GelSYbaff7293-e1a3-d1f2-e053-2995a90a93ca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-953-8036800095380226 g in 1 BOTTLE (36800-953-80) 226 g2018-12-050000-00-00NoNoCurrent