FDA.reportPublic FDA data

Family Wellness

Product NDC
55621-007
11-digit product format
556210007
Labeler code
55621
Product ID
55621-007_0882dc65-a451-daec-e063-6394a90a10ff
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
2; .1 g/100g; g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100g
ZINC ACETATE.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1087026Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fefbe351-1cd9-4a2f-a43d-51e2c4eb180bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-007-01Family Wellness1 in 1 BOXCREAM14
55621-007-01Family Wellness28 g in 1 TUBECREAM284

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40FAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
ZINC ACETATEACTIVE INGREDIENTFM5526K07AFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
ZINC CATIONACTIVE MOIETY13S1S8SF37FAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4FAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
LAURETH-23INACTIVE INGREDIENTN72LMW566GFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RFAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-007FAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231025_fefbe351-1cd9-4a2f-a43d-51e2c4eb180b.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 94 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mqforu Pain PatchPAIN PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.1f878abd-54cd-1963-e063-6294a90a18842025-04-22WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED ROLL ONLIDOCAINE, MENTHOLCompass Health Brands Corp.2c25fa5e-9546-ba74-e063-6294a90aadf42025-04-22WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED BALMLIDOCAINE, MENTHOLCompass Health Brands Corp.2bd8cfb6-ab6c-9e04-e063-6294a90a2d522025-04-22WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINEPharmheal32e57c0f-d138-88dc-e063-6394a90ac0852025-04-16WarningsExact identifier
application number: M017
COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-PatchMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd32b7d73c-a191-7843-e063-6394a90aa6312025-04-14WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEMARCELLA HEALTH32c153c7-de30-504e-e063-6294a90a40202025-04-14WarningsExact identifier
application number: M017
Dollar General Cold-Hot Medicated PatchesMENTHOLDOLGENCORP, LLCe13ab4d3-eb58-4874-925a-6a59df4dd29a2025-04-14WarningsExact identifier
application number: M017
AY BENDITO - PAIN RELIEFCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCb97f6b71-7de7-3217-e053-2a95a90aa4262025-04-14WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCbbf0d85e-269d-0342-e053-2995a90ac63c2025-04-14WarningsExact identifier
application number: M017
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC71a36691-9d9e-479d-bfdc-6f6b192ad2d02025-04-11WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedda3358ae-8679-6045-e053-2a95a90a50e32025-04-10WarningsExact identifier
application number: M017
JointflexJOINTFLEXStrides Consumer LLCb82ec69c-bd00-400b-bd94-ac15fb620f9b2025-04-09WarningsExact identifier
application number: M017
Zepol Topical AnalgesicCAMPHOR, MENTHOLLaboratorios Zepol S.A.ca20ade6-9b35-40bb-b3b2-fc3a0e1eece92025-04-09WarningsExact identifier
application number: M017
JointflexCAMPHORStrides Consumer LLCcb5ca02b-0bc1-4b0b-b4b1-abef3222aa562025-04-09WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC32456887-aa09-8912-e063-6394a90a4ae72025-04-08WarningsExact identifier
application number: M017
MUSCLEMENTHOLWATER-JEL TECHNOLOGIES1af399af-07b0-4899-9bcc-1e244b63b1cf2025-04-08WarningsExact identifier
application number: M017
Lidocaine with MentholLIDOCAINE HCL AND MENTHOLKareway Product, Inc.9ee46a5b-d00c-4254-e053-2995a90aeb3a2025-04-08WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC324802c9-e2c2-bf74-e063-6394a90a86972025-04-08WarningsExact identifier
application number: M017
OARS AND ALPS MUSCLE RECOVERY BALMMENTHOL, METHYL SALICYLATECosco International, Inc8745802f-018d-4cf8-bbf3-3b04c8f545382025-04-08WarningsExact identifier
application number: M017
NOVUM APRMENTHOLNOVUM SOLUTIONS INC1b869a1f-5787-4d03-a546-43a8217b2b2c2025-04-07WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNfefbe351-1cd9-4a2f-a43d-51e2c4eb180b4
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDfefbe351-1cd9-4a2f-a43d-51e2c4eb180b4
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYfefbe351-1cd9-4a2f-a43d-51e2c4eb180b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55621-007-01556210007011 TUBE in 1 BOX (55621-007-01) / 28 g in 1 TUBE1 tube2013-11-010000-00-00NoNoCurrent