FDA.reportPublic FDA data

Serum X Pain Relief Gel

Manufacturer
AO Biologix, LLC | TRI-PAC, INC.
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:42:37

Label at a glance#

ProductSerum X
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: consult a doctor

Storage and handling

store in a cool, dry place away from light this package is child-resistant

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

Lidocaine Hydrochloride 0.5%...............Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition worsens
  • any allergic reaction occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reacho f children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily

Children under 2 years of age:consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store in a cool, dry place away from light
  • this package is child-resistant

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Hydroxyethylcellulose, Disodium Phosphate, Sodium Phosphate, Methylparaben, Superoxide Dismutase, Propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

Call 855-910-1252 Monday-Friday; 9am-5pm MST.

SerumX.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AO Biologix

Serum X

Pain Relief Gel

Fast Acting Lidocaine

With Antioxidant Properties

30mL/1 Fl. oz.

11

22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011849lidocaine HCl 0.5 % Topical GelPSN2
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCD2
1011849lidocaine hydrochloride 0.5 % Topical GelSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82317-00182317-001-30, 82317-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
SODIUM PHOSPHATESE337SVY37IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE)W2T4YRA9ADIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

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
Serum XLIDOCAINE HYDROCHLORIDEAO Biologix, LLCe07b6268-6400-6849-e053-2a95a90a8b3e2024-12-11WarningsExact identifier
ndc (package): 82317-001-30
ndc (package): 82317-001-01
ndc (product): 82317-001
ndc11 (package): 82317000130
ndc11 (package): 82317000101
spl id: 29010efb-0f31-6296-e063-6294a90a443e
spl set id: e07b6268-6400-6849-e053-2a95a90a8b3e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.