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 77 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl ozMENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN)BH GLOBAL HOLDINGS LLC1ddddbb6-2d01-c894-e063-6394a90acd582025-10-01WarningsExact identifier
application number: M017
Tylenol Precise Pain Relieving Lidocaine 4%LIDOCAINEKenvue Brands LLC36a95afd-97e5-2271-e063-6394a90aea182025-09-30WarningsExact identifier
application number: M017
Capsaicin HeatCAPSAICINUniversal Distribution Center LLCb3b40f77-3b0b-4111-968b-f3a87a5701fa2025-09-29WarningsExact identifier
application number: M017
Caring Mills Menthol 4% Roll-OnMENTHOLVeridian Healthcaref4308c74-0860-4265-aeaf-a01301cca27a2025-09-29WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED LARGEMENTHOLUniversal Distribution Center LLCd6780230-aa96-4055-b054-be41358568b62025-09-29WarningsExact identifier
application number: M017
COLD AND HOT MEDICATEDMENTHOLUniversal Distribution Center LLCc19aa620-401d-43c4-804c-3611cc39e9f22025-09-29WarningsExact identifier
application number: M017
UniShield First Aid BurnLIDOCAINE HCLUnishieldf729c557-da4b-3fb5-e053-6394a90a41962025-09-28WarningsExact identifier
application number: M017
Xpect HydrocortisoneHYDROCORTISONECintas Corporation45ef9be4-54c4-4d85-966b-27708313ded42025-09-26WarningsExact identifier
application number: M017
Zhuifeng Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3f12da60-26d1-4407-8e02-c3213ea3ad2a2025-09-26WarningsExact identifier
application number: M017
Gutong Tiegao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD5a5c3759-90e0-4a93-99cf-ddbf00aba10d2025-09-26WarningsExact identifier
application number: M017
Zhuanggu Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTDe3e98530-ce4d-47b9-9383-3088814034eb2025-09-26WarningsExact identifier
application number: M017
GUTONG TIEGAO PAIN RELIEVINGCAMPHOR AND MENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3adfac16-ea7b-47df-89f5-91bbd09c4fe12025-09-26WarningsExact identifier
application number: M017
Xpect Sting WipesBENZOCAINE 6%Cintas Corporationfeeae00d-e266-4ae4-90d2-524da38fa8132025-09-26WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreens Company0b4053a8-6c1c-621d-e063-6394a90a4f562025-09-25WarningsExact identifier
application number: M017
Unishield 1%HYDROCORTISONEUnishield4871a67f-fbb8-4a6b-ace4-d343490289082025-09-24WarningsExact identifier
application number: M017
Xpect Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDECintas Corporationa373b2c3-5c58-4b64-9358-bdf42dfce08c2025-09-24WarningsExact identifier
application number: M017
Xpect Burn CareBURN CARECintas Corp3665eb99-9602-4949-8af4-3ce7ed24303c2025-09-23WarningsExact identifier
application number: M017
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC80a1bc65-2986-491f-a062-307d28b08ccb2025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 16% Pain Relief LiquidMENTHOLVeridian Healthcared932050d-2a9a-4a5e-b45d-0a7a864582e02025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 4% Pain ReliefMENTHOLVeridian Healthcarefa121e5f-94b5-4c1d-9c4e-85bb8ede39452025-09-22WarningsExact 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