Family Wellness

Product NDC
69571-005
11-digit product format
695710005
Labeler code
69571
Product ID
69571-005_08a16eed-ba21-b1fa-e063-6294a90a6615
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Dosage form
CREAM
Route
TOPICAL
Labeler
FRONT PHARMACEUTICAL PLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-29
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
fde2069b-344e-46da-bb95-c5113e0f35d6Available 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
69571-005-01Family Wellness28 g in 1 TUBECREAM284
69571-005-02Family Wellness1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69571-005FAMILY WELLNESS (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [FRONT PHARMACEUTICAL PLC]4Current NDC, Legacy NDC, 2 package rows20231027_fde2069b-344e-46da-bb95-c5113e0f35d6.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 146 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NATURES CRAFT LIDOCAINE Male Genital DesensitizerLIDOCAINE HYDROCHLORIDENatures Design Products LLC61bf1776-5c6c-4307-8348-41fa601640172023-11-11WarningsExact identifier
application number: M017
CLEAN REMEDIES CR PAIN RELIEFMENTHOLClean Remedies, LLCaea9291d-3244-401c-9607-e91107228faa2023-11-11WarningsExact identifier
application number: M017
Arth ArrestMETHYL NICOTINATE, CAPSAICINKey 2 Health, Inc.495034ac-dbf5-4c55-906b-6ffcbcfd5bc22023-11-11WarningsExact identifier
application number: M017
KINETIC ICE Muscle and Joint Pain Relief CreamMENTHOLNo Reason, LLC565f0e20-e534-41db-ba20-e726d578405f2023-11-11WarningsExact identifier
application number: M017
KARMA RUB Elemental Pain ReliefLIDOCAINE HYDROCHLORIDEElemental Bliss LLCc224fb1b-827f-461e-a58f-4020700c3e0d2023-11-11WarningsExact identifier
application number: M017
Bakers Best Arthritis Pain Relief with Hemp SeedHISTAMINE DIHYDROCHLORIDEBaker's Best Health Products, LLC46415d28-99b5-4c9e-bde9-1c703595f6712023-11-11WarningsExact identifier
application number: M017
Dr PAINES Pain ReliefMENTHOLDOCTOR PAINE'S MEDICAL, LLC79d2b332-051e-48c1-afe8-6d4468cd18782023-11-11WarningsExact identifier
application number: M017
INTIMALE Maximum Strength DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED25b9ade3-72b0-4b86-8c48-90310a26806f2023-11-11WarningsExact identifier
application number: M017
POWERECT Max Power Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED25a1c926-9543-44a7-865e-a4b6e1a40cbe2023-11-11WarningsExact identifier
application number: M017
SKINS DELAY Maximum Strength LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED172efe5d-28b8-443c-b3f9-4296691890812023-11-11WarningsExact identifier
application number: M017
GASPARI Ageless Pain Relief CreamMENTHOLGASPARI ANTI-AGING LLCea806089-688b-4944-ad69-86f366509eb52023-11-11WarningsExact identifier
application number: M017
ZENSEZONE Arthmed Temporary Pain Relief CreamCAPSAICIN, MENTHOL, METHYL SALICYLATEZENSEZONE LLCc5778f22-c411-4bd7-b2af-45e3fee15fd22023-11-11WarningsExact identifier
application number: M017
PRFC HEMP Topical AnalgesicMENTHOLDOBEST INC722da9d1-91d7-45be-adb1-8d6a22aa83ac2023-11-11WarningsExact identifier
application number: M017
AMP RELIEF Pain Relief CreamMENTHOLCOASTAL FORMULAS LLC84ea496e-ab54-4882-93ef-600f8eb33cb42023-11-11WarningsExact identifier
application number: M017
AMP RELIEF Pain Relief CreamMENTHOLCOASTAL FORMULAS LLC39564c67-49ab-42d4-a391-792ac69180c02023-11-11WarningsExact identifier
application number: M017
LIDOSOLVE PAIN RELIEFLIDOCAINE HYDROCHLORIDEHENNIKA HEALTH, LLC3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e22023-11-11WarningsExact identifier
application number: M017
AMINO ACTIVE Topical Analgesic CreamHISTAMINE DIHYDROCHLORIDEVIREO SYSTEMS, INC.591b1e7e-a8c0-4640-a592-4e0f3538a40e2023-11-11WarningsExact identifier
application number: M017
NERVE ACTIVE Pain Relief CreamMENTHOLTOP DOG DIRECT, LLCa8b85dcb-fd3e-4340-a945-609fc741443c2023-11-11WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine BackLIDOCAINEGeri-Gentle Corporatione4427928-c063-9ca6-e053-2995a90a1aa12023-11-10WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch Arm and NeckMENTHOLGeri-Gentle Corporatione4429f70-667e-662b-e053-2a95a90a62ba2023-11-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNfde2069b-344e-46da-bb95-c5113e0f35d64
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDfde2069b-344e-46da-bb95-c5113e0f35d64
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYfde2069b-344e-46da-bb95-c5113e0f35d64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69571-005-016957100050128 g in 1 TUBE28 gHistorical
69571-005-02695710005021 TUBE in 1 BOX (69571-005-02) / 28 g in 1 TUBE (69571-005-01) 1 tube2017-03-290000-00-00NoNoCurrent