FDA.reportPublic FDA data

Derma Numb

Product NDC
53200-001
11-digit product format
532000001
Labeler code
53200
Product ID
53200-001_a5d9e551-6401-4b22-b7fc-92031b40c295
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCI
Dosage form
SPRAY
Route
TOPICAL
Labeler
Atlas Tat Inc.
Application
part348
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-15
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53200-001-012019-11-27C16284748780-19855d018-e3b4-cd31-e053-dbdaa90ab51aDerma Numb Tattoo Anesthetic Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53200-001-01Derma Numb28.35 g in 1 BOTTLE, SPRAYSPRAY28.351

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ADERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1
LIDOCAINEACTIVE MOIETY98PI200987DERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PKDERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4DERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CDERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1
YUCCA GLAUCA ROOTINACTIVE INGREDIENT1A15YBH7N1DERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53200-001DERMA NUMB (LIDOCAINE HCI) SPRAY [ATLAS TAT INC.]1Legacy NDC, 1 package rows20121004_84c65be3-bee5-4da1-aba5-38779a6d9cdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1312265DERMA NUMB 4 % Topical SprayPSN84c65be3-bee5-4da1-aba5-38779a6d9cdc1
1045432lidocaine HCl 4 % Topical SprayPSN84c65be3-bee5-4da1-aba5-38779a6d9cdc1
1312265lidocaine hydrochloride 40 MG/ML Topical Spray [Derma Numb]SBD84c65be3-bee5-4da1-aba5-38779a6d9cdc1
1045432lidocaine hydrochloride 40 MG/ML Topical SpraySCD84c65be3-bee5-4da1-aba5-38779a6d9cdc1
1312265Derma Numb 4 % Topical SpraySY84c65be3-bee5-4da1-aba5-38779a6d9cdc1
1312265Derma Numb 40 MG/ML Topical SpraySY84c65be3-bee5-4da1-aba5-38779a6d9cdc1
1045432lidocaine HCl 4 % Topical SpraySY84c65be3-bee5-4da1-aba5-38779a6d9cdc1
1045432lidocaine HCl 4 % Topical Spray GelSY84c65be3-bee5-4da1-aba5-38779a6d9cdc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53200-001-015320000010128.35 g in 1 BOTTLE, SPRAY28.35 gHistorical