FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
13925-159
Requested package NDC
13925-159-01
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 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
1010835Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1c0abe84-5404-404e-b882-e910e4d43ffbAvailable 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
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#

NDC, Effective, Related label table
NDCEffectiveRelated label
13925-159-012024-01-31Lidocaine 3% Cream
13925-159-032024-01-31Lidocaine 3% Cream
13925-159-012022-02-08Lidocaine 3% Cream
13925-159-032022-02-08Lidocaine 3% Cream
13925-159-012022-01-28Lidocaine 3% Cream
13925-159-032022-01-28Lidocaine 3% Cream

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESeton Pharmaceuticals1c0abe84-5404-404e-b882-e910e4d43ffb2024-01-30Warnings, Adverse reactionsExact identifier
ndc (package): 13925-159-01
ndc (product): 13925-159
ndc11 (package): 13925015901

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