FDA.reportPublic FDA data

Family Wellness

Product NDC
55621-016
11-digit product format
556210016
Labeler code
55621
Product ID
55621-016_08ad56e9-b3d4-3128-e063-6394a90ab417
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE, RESORCINOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-20
Substance
BENZOCAINE; RESORCINOL
Active strength
20; 3 g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g
RESORCINOL3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
YUL4LO94HKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637518Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df540eb8-6773-4647-9cc2-c3fd14d7355eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-016-01Family Wellness1 in 1 CARTONCREAM12
55621-016-01Family Wellness28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-016FAMILY WELLNESS (BENZOCAINE, RESORCINOL) CREAM [ZHEJIANG JINGWEI PHARMACEUTIC AL CO., LTD.]2Current NDC, Legacy NDC, 2 package rows20231027_df540eb8-6773-4647-9cc2-c3fd14d7355e.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 31 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESTRATEGIC SOURCING SERVICES LLCec0c9602-35cc-4bb6-b853-794a8b5bf42e2026-03-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4c06c4a4-557b-8bb1-e063-6294a90a91252026-03-02WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Old East Main Co.49173ec8-c94a-44c9-8a13-0f4b01b96cd62026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEOld East Main Co.6d87547f-bf4c-4dda-bd9d-32b576afd8052026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLClinical Resolution Laboratory, Inc.80af21f5-dba8-42b0-8a65-ac5a94d83ca82026-03-02WarningsExact identifier
application number: M017
Icy Hot Lidocaine No-MessLIDOCAINE HYDROCHLORIDEChattem, Inc.347f9a18-8ab6-47d3-9610-5b4e9ca5d53a2026-03-02WarningsExact identifier
application number: M017
Gold Bond Maximum Strength Foot Pain ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLC8e469076-2f5a-4de8-8d13-a38c072b9af82026-03-01WarningsExact identifier
application number: M017
HealthWise Pain Relief LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcare48ecbab9-13e0-d0fa-e063-6294a90a6ff22026-02-28WarningsExact identifier
application number: M017
NUMBING CREAMSLIDOCAINEYongchun Lihui Trading Co., Ltd.3b5e1a74-5946-4f1f-e063-6394a90a404b2026-02-27WarningsExact identifier
application number: M017
Pain Relieving GelLIDOCAINE HYDROCHLORIDEChain Drug Marketing Associationb55b7253-2fd2-45cc-b94c-e92395ab0d2b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
application number: M017
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFPAI Holdings, LLC dba PAI Pharma963978de-8295-47ee-9b06-64c3521aa9942026-02-26WarningsExact identifier
application number: M017
Tommie Copper Cooling Roller Lavender ScentMENTHOL 4%Tommie Copper, Inc.4bbfd4d1-9036-bc20-e063-6394a90a3feb2026-02-26WarningsExact identifier
application number: M017
HQLSEY QUIT SMOKING PATCHESQUIT SMOKING PATCHESHansen Pharmaceutical Investment Co., Limited4ba317fb-714a-05cb-e063-6394a90a382f2026-02-25WarningsExact identifier
application number: M017
Advanced Pain Relief Cream With 5 % Natural MentholMENTHOLAllure Labs4bab9c43-86d4-dad2-e063-6394a90ac0952026-02-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamPSNdf540eb8-6773-4647-9cc2-c3fd14d7355e2
637518benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal CreamSCDdf540eb8-6773-4647-9cc2-c3fd14d7355e2
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamSYdf540eb8-6773-4647-9cc2-c3fd14d7355e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55621-016-01556210016011 TUBE in 1 CARTON (55621-016-01) / 28 g in 1 TUBE1 tube2017-08-200000-00-00NoNoCurrent