FDA.reportPublic FDA data

GREEN GUARD Topical Pain Relief

Product NDC
78495-132
11-digit product format
784950132
Labeler code
78495
Product ID
78495-132_3239add3-7926-c1a3-e063-6394a90a1310
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCI
Dosage form
SPRAY
Route
TOPICAL
Labeler
Ultra Distributors Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-19
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
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
GREEN GUARD Topical Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010769

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78495-132-012025-04-07C16284748780-12cef2736-afb2-d83d-e063-dadaa90ab31f78495-132
78495-132-012025-01-30C16284748780-12cef2736-afb2-d83d-e063-dadaa90ab31f78495-132

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78495-132-01GREEN GUARD Topical Pain Relief59.1 mL in 1 BOTTLE, SPRAYSPRAY59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78495-132GREEN GUARD TOPICAL PAIN RELIEF (LIDOCAINE HCI) SPRAY [ULTRA DISTRIBUTORS INC]2Current NDC, Legacy NDC, 1 package rows20250409_b6f0041c-47fc-0bcd-e053-2a95a90ab1f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010769lidocaine HCl 2 % Topical SprayPSNb6f0041c-47fc-0bcd-e053-2a95a90ab1f92
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCDb6f0041c-47fc-0bcd-e053-2a95a90ab1f92
1010769lidocaine hydrochloride 2 % Topical SpraySYb6f0041c-47fc-0bcd-e053-2a95a90ab1f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78495-132-017849501320159.1 mL in 1 BOTTLE, SPRAY (78495-132-01) 59.1 ml2020-12-190000-00-00NoNoCurrent