FDA.reportPublic FDA data

RECTICARE

Product NDC
0496-0980
11-digit product format
004960980
Labeler code
0496
Product ID
0496-0980_297a27f1-089b-38aa-e063-6394a90adea1
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine and glycerin
Dosage form
CLOTH
Route
TOPICAL
Labeler
Ferndale Laboratories, Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-01
Substance
GLYCERIN; LIDOCAINE
Active strength
200; 50 mg/g; mg/g
Pharmacologic classes
Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RECTICARE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN200 mg/g
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, 98PI200987
Rxcui1602013, 1602019

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0496-0980-65RECTICARE12 in 1 CARTONCLOTH123
0496-0980-76RECTICARE6 g in 1 POUCHCLOTH63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0496-0980-65EA - Each0496-0980046a699c-669a-453e-b9af-c8e82d87b28412022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0980RECTICARE (LIDOCAINE AND GLYCERIN) CLOTH [FERNDALE LABORATORIES, INC.]3Current NDC, Legacy NDC, 2 package rows20241220_2b94136a-4975-2925-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1602013lidocaine HCl 5 % / glycerin 20 % Medicated PadPSN2b94136a-4975-2925-e054-00144ff88e883
1602019RectiCare 5 % / 20 % Medicated PadPSN2b94136a-4975-2925-e054-00144ff88e883
1602019glycerin 200 MG/ML / lidocaine 43 MG/ML Medicated Pad [Recticare Wipes]SBD2b94136a-4975-2925-e054-00144ff88e883
1602013glycerin 200 MG/ML / lidocaine 43 MG/ML Medicated PadSCD2b94136a-4975-2925-e054-00144ff88e883
1602013glycerin 20 % / lidocaine 4.3 % (as lidocaine HCl 5 % ) Medicated PadSY2b94136a-4975-2925-e054-00144ff88e883
1602013glycerin 20 % / lidocaine HCl 5 % Medicated PadSY2b94136a-4975-2925-e054-00144ff88e883
1602019Recticare Wipes (glycerin 20 % / lidocaine 4.3 % (as lidocaine HCl 5 % )) Medicated PadSY2b94136a-4975-2925-e054-00144ff88e883
1602019Recticare Wipes (glycerin 20 % / lidocaine HCl 5 % ) Medicated PadSY2b94136a-4975-2925-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0496-0980-650049609806512 POUCH in 1 CARTON (0496-0980-65) / 6 g in 1 POUCH (0496-0980-76) 12 pouch2016-01-010000-00-00NoNoCurrent
0496-0980-76004960980766 g in 1 POUCH6 gHistorical