Serum X

Product NDC
82317-001
11-digit product format
823170001
Labeler code
82317
Product ID
82317-001_29010efb-0f31-6296-e063-6294a90a443e
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
AO Biologix, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-21
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
.5 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
Serum X
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1011849

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82317-001-01Serum X1 in 1 PACKAGEGEL12
82317-001-01Serum X0.5 g in 1 PACKETGEL0.52
82317-001-30Serum X30 g in 1 BOTTLEGEL302
82317-001-30Serum X1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82317-001SERUM X (LIDOCAINE HYDROCHLORIDE) GEL [AO BIOLOGIX, LLC]2Current NDC, Legacy NDC, 4 package rows20241213_e07b6268-6400-6849-e053-2a95a90a8b3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011849lidocaine HCl 0.5 % Topical GelPSNe07b6268-6400-6849-e053-2a95a90a8b3e2
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCDe07b6268-6400-6849-e053-2a95a90a8b3e2
1011849lidocaine hydrochloride 0.5 % Topical GelSYe07b6268-6400-6849-e053-2a95a90a8b3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82317-001-01823170001011 PACKET in 1 PACKAGE (82317-001-01) / .5 g in 1 PACKET1 packet2022-07-010000-00-00NoNoCurrent
82317-001-30823170001301 BOTTLE in 1 CARTON (82317-001-30) / 30 g in 1 BOTTLE1 bottle2022-04-210000-00-00NoNoCurrent