FDA.reportPublic FDA data

PLIAGLIS

Product NDC
71085-100
11-digit product format
710850100
Labeler code
71085
Product ID
71085-100_4c97e0ed-1d3a-44af-e063-6294a90ae75f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Tetracaine
Dosage form
CREAM
Route
TOPICAL
Labeler
IPG PHARMACEUTICALS, INC.
Application
NDA021717
Marketing category
NDA
Marketing start
2026-03-06
Substance
LIDOCAINE; TETRACAINE
Active strength
70; 70 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PLIAGLIS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE70 mg/g
TETRACAINE70 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, 0619F35CGV
Rxcui687443, 728126

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71085-100-30PLIAGLIS1 in 1 CARTONCREAM11
71085-100-30PLIAGLIS30 g in 1 TUBECREAM301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-100-30GM - Gram71085-100298b48ae-701c-4550-bf6b-733b3940ba6a12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
687443lidocaine 7 % / tetracaine 7 % Topical CreamPSNd854faa5-0af8-4684-b5cd-a0b8a91fb7cd1
728126Pliaglis 7 % / 7 % Topical CreamPSNd854faa5-0af8-4684-b5cd-a0b8a91fb7cd1
728126lidocaine 70 MG/ML / tetracaine 70 MG/ML Topical Cream [Pliaglis]SBDd854faa5-0af8-4684-b5cd-a0b8a91fb7cd1
687443lidocaine 70 MG/ML / tetracaine 70 MG/ML Topical CreamSCDd854faa5-0af8-4684-b5cd-a0b8a91fb7cd1
687443lidocaine 7 % / tetracaine 7 % Topical CreamSYd854faa5-0af8-4684-b5cd-a0b8a91fb7cd1
728126Pliaglis (lidocaine 7 % / tetracaine 7 % ) Topical CreamSYd854faa5-0af8-4684-b5cd-a0b8a91fb7cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71085-100-30710850100301 TUBE in 1 CARTON (71085-100-30) / 30 g in 1 TUBE1 tube2026-03-06NoNoCurrent