RectoProtect

Product NDC
71399-0050
11-digit product format
713990050
Labeler code
71399
Product ID
71399-0050_2a38ffe4-f534-4937-b818-3da6a60f8f46
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Akron Pharma Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-06
Substance
LIDOCAINE
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
RectoProtect
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1366789

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0050-2RectoProtect1 in 1 CARTONCREAM14
71399-0050-2RectoProtect30 g in 1 PACKAGECREAM304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0050-1GM - Gram71399-0050868b1e18-50ca-42f7-b7f4-500e70e5a0f812025-05-14
71399-0050-2GM - Gram71399-00501c43f645-0dc8-4675-950a-dece6f1b266512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0050RECTOPROTECT (LIDOCAINE) CREAM [AKRON PHARMA INC.]4Current NDC, 2 package rows20250120_1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366789lidocaine 5 % Rectal CreamPSN1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb4
1366789lidocaine 50 MG/ML Rectal CreamSCD1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb4
1366789lidocaine 5 % Rectal CreamSY1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-0050-2713990050021 PACKAGE in 1 CARTON (71399-0050-2) / 30 g in 1 PACKAGE1 package2025-01-06NoNoCurrent