FDA.reportPublic FDA data

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 20 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stud 100 Male Genital DesensitizerLIDOCAINEPound International Corpd075656e-b13f-4a1d-bbb6-501e642698d52026-05-12WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc13ce57d0-b1c5-4685-ad7d-a562d9d8fc862026-05-12WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
application number: M017
Cool and HeatMENTHOLAMERISOURCE BERGENf2bb0e8e-c4cd-0e8c-e053-2995a90a6df72026-05-11WarningsExact identifier
application number: M017
Instaflex Extra Strength Pain Relief CreamMENTHOL, METHYL SALICYLATEHealthy Directions, LLCd058c64d-0e4f-45aa-8f52-804961b562e32026-05-11WarningsExact identifier
application number: M017
BonicaEaseX Hot Capsicum Pain RelievingCAPSICUMPlanet (Anhui) Pharmaceutical Co.,Ltdca6e48af-af6d-4808-a576-0319d2080d382026-05-11WarningsExact identifier
application number: M017
BonicaEaseX Pain Relieving LidocaineLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.7486fe89-a377-4a37-997d-e3bd16b891a72026-05-11WarningsExact identifier
application number: M017
YYSDMVY NUMBING CreamLIDOCAINE 4% NUMBING CREAMJiangxi Yudexi Pharmaceutical Co., LTD5195f5ec-8524-77f5-e063-6294a90abdc22026-05-11WarningsExact identifier
application number: M017
Lightning X Burn Relief GelLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.515eb4cc-63af-c11d-e063-6294a90a13ca2026-05-09WarningsExact identifier
application number: M017
Albertson Lidocaine, Menthol Pain Relief Medicated PatchLIDOCAINE AND MENTHOLSafewaydc647647-90ec-6beb-e053-2a95a90a79822026-05-09WarningsExact identifier
application number: M017
5 Elementum Lidocaine Male Genital DesensitizerLIDOCAINE MALE GENITAL DESENSITIZERMSVENTURESGROUP O514b1738-886e-a95d-e063-6294a90aa7072026-05-08WarningsExact identifier
application number: M017
Kroger Muscle Rub CreamMENTHOL, CAMPHOR, METHYL SALICYLATEKroger Co.45c8c79a-b4b4-d4be-e063-6394a90a92512026-05-08WarningsExact identifier
application number: M017
Walmart Equate Aloe Sunburn Relief CoolingLIDOCAINEWAL-MART STORES INC.51540f6b-596f-bc47-e063-6294a90a46ae2026-05-08WarningsExact identifier
application number: M017
Capsaicin 0.035% creamCAPSAICINMedcore LLC0236e1e4-c26c-4fff-a83b-143ce26d93bf2026-05-07WarningsExact identifier
application number: M017
Lidocaine 4% CreamLIDOCAINEMedcore LLC111cb421-ba3b-4772-ab60-d31eb41831682026-05-07WarningsExact identifier
application number: M017
Lidocaine 5% CreamLIDOCAINEMedcore LLC15d02b42-bf8b-486a-a081-f6d17cc11ec72026-05-07WarningsExact identifier
application number: M017
JenGufun LIDOCAINE Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Kangdi Medical Devices Co., Ltd.51363a41-5dcc-6a3b-e063-6294a90a6c272026-05-07WarningsExact identifier
application number: M017
LidoxiLIDOCAINET&T Pharma Holdings LLC513c517e-c098-02aa-e063-6294a90ac8a42026-05-07WarningsExact identifier
application number: M017
Harris Teeter HydrocortisoneHYDROCORTISONEHARRIS TEETER LLC4e8199f8-96ec-5342-e063-6294a90afb2d2026-05-07WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.5114cdba-96a1-c399-e063-6294a90aac122026-05-06WarningsExact 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