FDA.reportPublic FDA data

RECTICARE

Product NDC
0496-0892
11-digit product format
004960892
Labeler code
0496
Product ID
0496-0892_2979ed4e-4ce3-bd7d-e063-6294a90acb9f
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Ferndale Laboratories, Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-09
Substance
LIDOCAINE
Active strength
50 mg/g
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
RECTICARE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366789Internal RxNorm lookup
1422546Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
49cb48cf-7a26-4d7a-887f-2e98261d269dAvailable on FDA.report

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
0496-0892-15RECTICARE15 g in 1 TUBECREAM159
0496-0892-30RECTICARE30 g in 1 TUBECREAM309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0496-0892-15GM - Gram0496-08920f6c74fc-7d07-4b37-9b38-3facd17f742e12015-01-05
0496-0892-30GM - Gram0496-0892e3b12c84-e911-4934-8685-18c08c0b6e8f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987RECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
LIDOCAINEACTIVE MOIETY98PI200987RECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0RECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHRECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ERECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JRECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSRECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62RECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKRECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RRECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0892RECTICARE (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]9Current NDC, Legacy NDC, 2 package rows20241219_49cb48cf-7a26-4d7a-887f-2e98261d269d.zip

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 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsExact identifier
application number: M015
CVS Topical Anesthetic HemorrhoidalDIBUCAINECVS PHARMACY, INC9f3d4fdb-ad82-4ab8-8a9e-252d027068ab2026-07-25WarningsExact identifier
application number: M015
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
application number: M015
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEKORVIA GLOBAL Inc.5690db03-4d62-9660-e063-6394a90a2fc02026-07-14WarningsExact identifier
application number: M015
Gembooxt Topical Numbing CreamLIDOCAINE HCLGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-07-13WarningsExact identifier
application number: M015
Zmztuhua Numbing CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.56417dc6-c14b-ad17-e063-6294a90af7e52026-07-10WarningsExact identifier
application number: M015
Tina Davies IceCreamLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC6a2b3199-f405-4455-9a02-8885d24eef9c2026-07-09WarningsExact identifier
application number: M015
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELH E B09b814f4-86b5-4810-bf52-cc88396451c22026-07-07Warnings, Adverse reactionsExact identifier
application number: M015
Witch HazelWITCH HAZELADUSA Distribution, LLCc50d0496-6f09-43c2-9383-3250885968c92026-06-29Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd55260a3e-637a-c53b-e063-6394a90a1b092026-06-27WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens20c41406-99b2-bc89-e063-6294a90aed732026-06-25WarningsExact identifier
application number: M015
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
application number: M015
tina davies IceCream HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd2026-06-24WarningsExact identifier
application number: M015
Haemorrhoidal Pain ReliefANORECTAL CREAMNeilMed Pharmaceuticals Inc544a9d6f-4eaa-613e-e063-6294a90a0c502026-06-15WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-06-15WarningsExact identifier
application number: M015
Dr.Seymour Butts HemorrhoidLIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4981c7d9-53ee-2a7b-e063-6394a90add012026-06-12WarningsExact identifier
application number: M015
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5b7c4c-feac-4eeb-e063-6294a90a57482026-06-11WarningsExact identifier
application number: M015
tina davies IceJelly HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC580559bf-d91f-4bb3-9c9b-b7e2cd0686fd2026-06-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366789lidocaine 5 % Rectal CreamPSN49cb48cf-7a26-4d7a-887f-2e98261d269d9
1422546RectiCare 5 % Rectal CreamPSN49cb48cf-7a26-4d7a-887f-2e98261d269d9
1422546lidocaine 50 MG/ML Rectal Cream [Recticare]SBD49cb48cf-7a26-4d7a-887f-2e98261d269d9
1366789lidocaine 50 MG/ML Rectal CreamSCD49cb48cf-7a26-4d7a-887f-2e98261d269d9
1366789lidocaine 5 % Rectal CreamSY49cb48cf-7a26-4d7a-887f-2e98261d269d9
1422546Recticare 5 % Rectal CreamSY49cb48cf-7a26-4d7a-887f-2e98261d269d9
1422546Recticare 50 MG/ML Rectal CreamSY49cb48cf-7a26-4d7a-887f-2e98261d269d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0496-0892-150049608921515 g in 1 TUBE (0496-0892-15) 15 g2015-01-190000-00-00NoNoCurrent
0496-0892-300049608923030 g in 1 TUBE (0496-0892-30) 30 g2012-03-090000-00-00NoNoCurrent