Family Wellness Anorectal Lidocaine

Product NDC
55319-826
11-digit product format
553190826
Labeler code
55319
Product ID
55319-826_a1fbbda3-f05b-4db2-856d-f7e5471c91ca
Type
HUMAN OTC DRUG
Nonproprietary name
Anorectal Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
FAMILY DOLLAR (Family Wellness)
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-30
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Family Wellness Anorectal Lidocaine
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-826-28Family Wellness Anorectal Lidocaine28.3 g in 1 TUBECREAM28.33
55319-826-28Family Wellness Anorectal Lidocaine1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-826FAMILY WELLNESS ANORECTAL LIDOCAINE (ANORECTAL LIDOCAINE) CREAM [FAMILY DOLLAR (FAMILY WELLNESS)]3Current NDC, 2 package rows20241122_ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d.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 73 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nufabrx Lower Leg SleeveCAPSAICINNufabrx LLCb8e3e528-b7cd-e4b7-e053-2995a90a40292025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Ankle SleeveCAPSAICINNufabrx LLC013d60c7-a613-7cdf-e063-6294a90ad5842025-10-15WarningsExact identifier
application number: M017
Nufabrx Calf SleeveCAPSAICINNufabrx LLCbd9459c4-5596-746f-e053-2995a90a54002025-10-15WarningsExact identifier
application number: M017
Nufabrx Arm SleeveCAPSAICINNufabrx LLCa7993eaf-6488-a818-e053-2995a90a7ea62025-10-15WarningsExact identifier
application number: M017
Nufabrx Back WrapCAPSAICINNufabrx LLCe4f85ac8-57cb-46eb-e053-2995a90a9b1c2025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused SocksCAPSAICINNufabrx LLC013cb66f-8695-b69f-e063-6294a90a699c2025-10-15WarningsExact identifier
application number: M017
Nufabrx Neck WrapCAPSAICINNufabrx LLCe10b420c-500d-5738-e053-2a95a90a008f2025-10-15WarningsExact identifier
application number: M017
Nufabrx Knee SleeveCAPSAICINNufabrx LLCa5f455d4-5fc5-d516-e053-2a95a90a921e2025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused SocksCAPSAICINNufabrx LLC00d7d5bf-ee03-e73d-e063-6394a90a5d942025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Elbow SleeveCAPSAICINNufabrx LLC27ef3ef0-2f98-6672-e063-6294a90aeca42025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Wrist SleeveCAPSAICINNufabrx LLC22572cf9-fc0c-d327-e063-6394a90a21862025-10-15WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWALGREENSeff77965-dc7f-49af-e053-2995a90a1a972025-10-14WarningsExact identifier
application number: M017
Pleasure Balm Kama SutraBENZOCAINECosmetic Enterprises Ltdf370e3c4-65ca-4f3c-a5aa-70e198e681a22025-10-14WarningsExact identifier
application number: M017
Vanicream HC Anti-ItchHYDROCORTISONEPharmaceutical Specialties, Inc.28b06507-27a5-2cb1-e054-00144ff8d46c2025-10-14WarningsExact identifier
application number: M017
TrilogelLIDOCAINE HYDROCHLORIDETrifluent Pharma LLC22af7d63-6a56-4a38-a95b-0f88410b23cb2025-10-14WarningsExact identifier
application number: M017
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.40c63645-8ed3-82b3-e063-6294a90a52672025-10-13WarningsExact identifier
application number: M017
CramergesicMENTHOL, METHYL SALICYLATEThe Hygenic Company, LLCd0ffde7a-6942-74fc-e053-2a95a90a484a2025-10-13WarningsExact identifier
application number: M017
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
application number: M017
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINENanjing Anxing Medical Technology Co., Ltd.40c9b132-57ce-865e-e063-6394a90a20802025-10-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366789lidocaine 5 % Rectal CreamPSNed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d3
1366789lidocaine 50 MG/ML Rectal CreamSCDed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d3
1366789lidocaine 5 % Rectal CreamSYed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-826-28553190826281 TUBE in 1 CARTON (55319-826-28) / 28.3 g in 1 TUBE1 tube2023-09-30NoNoCurrent