Burn Relief Extra Strength

Product NDC
61566-279
11-digit product format
615660279
Labeler code
61566
Product ID
61566-279_386fb699-0ea0-e203-e063-6294a90a78e7
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine - 3.9%
Dosage form
CREAM
Route
TOPICAL
Labeler
Kool-Down Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-15
Substance
LIDOCAINE
Active strength
3.9 g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Burn Relief Extra Strength
Brand name suffix
Kool-Down
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE3.9 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui2108915, 2108920

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61566-279-04Burn Relief Extra StrengthKool-Down113 g in 1 BOTTLECREAM1133
61566-279-14Burn Relief Extra StrengthKool-Down128 g in 1 JARCREAM1283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61566-279BURN RELIEF EXTRA STRENGTH KOOL-DOWN (LIDOCAINE - 3.9%) CREAM [KOOL-DOWN INC]2Current NDC, Legacy NDC, 2 package rows20190223_827fec2f-db3c-adbb-e053-2a91aa0a7c17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2108920Kool-Down 3.9 % Topical CreamPSN827fec2f-db3c-adbb-e053-2a91aa0a7c173
2108915lidocaine 3.9 % Topical CreamPSN827fec2f-db3c-adbb-e053-2a91aa0a7c173
2108920lidocaine 39 MG/ML Topical Cream [Kool-Down]SBD827fec2f-db3c-adbb-e053-2a91aa0a7c173
2108915lidocaine 39 MG/ML Topical CreamSCD827fec2f-db3c-adbb-e053-2a91aa0a7c173
2108920Kool-Down 3.9 % Topical CreamSY827fec2f-db3c-adbb-e053-2a91aa0a7c173
2108920Kool-Down 39 MG/ML Topical CreamSY827fec2f-db3c-adbb-e053-2a91aa0a7c173
2108915lidocaine 3.9 % Topical CreamSY827fec2f-db3c-adbb-e053-2a91aa0a7c173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61566-279-0461566027904113 g in 1 BOTTLE (61566-279-04) 113 g2013-04-150000-00-00NoNoCurrent
61566-279-1461566027914128 g in 1 JAR (61566-279-14) 128 g2025-06-24NoNoCurrent