Lidocaine Hydrochloride

Product NDC
13925-159
11-digit product format
139250159
Labeler code
13925
Product ID
13925-159_9b24bc8c-a14f-4ef8-81ab-c4dbd627c3f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Seton Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-20
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
30 mg/g
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
Lidocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010835

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
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13925-159-01Lidocaine Hydrochloride28.35 g in 1 TUBECREAM28.357
13925-159-01Lidocaine Hydrochloride1 in 1 CARTONCREAM17
13925-159-03Lidocaine Hydrochloride85 g in 1 TUBECREAM857
13925-159-03Lidocaine Hydrochloride1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13925-159-01GM - Gram13925-1591faf4436-23d0-4184-a870-9f7ab24a8c2012012-07-24
13925-159-03GM - Gram13925-1596dabed4a-808a-4248-a341-ebbf0163db0b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
ALUMINUM SULFATEINACTIVE INGREDIENT34S289N54ELIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4LIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13925-159LIDOCAINE HYDROCHLORIDE CREAM [SETON PHARMACEUTICALS]7Current NDC, Legacy NDC, 4 package rows20240131_1c0abe84-5404-404e-b882-e910e4d43ffb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010835lidocaine HCl 3 % Topical CreamPSN1c0abe84-5404-404e-b882-e910e4d43ffb7
1010835lidocaine hydrochloride 30 MG/ML Topical CreamSCD1c0abe84-5404-404e-b882-e910e4d43ffb7
1010835lidocaine hydrochloride 3 % Topical CreamSY1c0abe84-5404-404e-b882-e910e4d43ffb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13925-159-01139250159011 TUBE in 1 CARTON (13925-159-01) / 28.35 g in 1 TUBE1 tube2011-06-200000-00-00NoNoCurrent
13925-159-03139250159031 TUBE in 1 CARTON (13925-159-03) / 85 g in 1 TUBE1 tube2011-06-200000-00-00NoNoCurrent