Hemporrhoid

Product NDC
76348-590
11-digit product format
763480590
Labeler code
76348
Product ID
76348-590_d58ff524-01c9-7574-e053-2995a90a7c52
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCL
Dosage form
CREAM
Route
TOPICAL
Labeler
Renu Laboratories, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-11-23
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
1 g/28g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
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
76348-590-022024-01-30C16284748780-11030e365-05d4-111a-e063-dadaa90a10e2HEMPORRHOID CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-590-01Hemporrhoid28 g in 1 TUBECREAM284
76348-590-02Hemporrhoid1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-590HEMPORRHOID (LIDOCAINE HCL) CREAM [RENU LABORATORIES, INC.]4Legacy NDC, 2 package rows20220115_b4df1e62-2585-fff7-e053-2a95a90aca06.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76348-590-017634805900128 g in 1 TUBE28 gHistorical
76348-590-02763480590021 TUBE in 1 BOX (76348-590-02) > 28 g in 1 TUBE (76348-590-01) 1 tube2020-11-230000-00-00NoNoCurrent