TheraCare 2% Diphenhydramine Anti-Itch Cream

Product NDC
71101-014
11-digit product format
711010014
Labeler code
71101
Product ID
71101-014_4085ade5-ebd1-ed55-e063-6394a90a82cf
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Veridian Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20; 1 mg/g; mg/g
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
TheraCare 2% Diphenhydramine Anti-Itch Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/g
ZINC ACETATE1 mg/g

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
5999b677-63dd-49c6-b5b8-7b3c117ecc5cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
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
71101-014-01TheraCare 2% Diphenhydramine Anti-Itch Cream35.4 g in 1 TUBECREAM35.41
71101-014-01TheraCare 2% Diphenhydramine Anti-Itch Cream1 in 1 CARTONCREAM11

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 124 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wegmans Aloe After Sun Gel with Lidocaine HCl External AnalgesicLIDOCAINE HYDROCHLORIDEWEGMANS FOOD MARKETS INCf70bc438-7ed8-f74d-e053-6394a90a2b3f2024-10-16WarningsExact identifier
application number: M017
EQUATE Sunburn relief with Aloe After SunLIDOCAINEWal-Mart Stores Incc25e1288-7ac6-41fc-ab65-26c379f288a72024-10-16WarningsExact identifier
application number: M017
Genuine First Aid Insect Sting Relief Pad 1 ctBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.b119ba37-0ee1-851a-e053-2995a90a85b12024-10-15WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company1a587e6e-88d1-4b01-abad-9a365dc64a4d2024-10-15WarningsExact identifier
application number: M017
TopCare Everyday After Sun CoolingLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATES LLCbaff7293-e1a3-d1f2-e053-2995a90a93ca2024-10-15WarningsExact identifier
application number: M017
Universal PAIN RELIEFLIDOCAINEUniversal Distribution Center LLCb132a4f2-1b1f-4e80-a183-f9add449065f2024-10-14WarningsExact identifier
application number: M017
Nervex Pain RelievingCAPSAICINVITA SCIENCES, LLCa39bba22-8c54-4252-9973-052dd2aaea362024-10-14WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENATURAL ESSENTIALS, INC.d07fdffd-bf7c-4950-9b2d-c06d54ef4c552024-10-14WarningsExact identifier
application number: M017
Walgreens CoolingLIDOCAINE HYDROCHLORIDEWALGREEN COMPANYbaffb272-436c-4ad8-e053-2a95a90a56fb2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefMENTHOLWALGREEN COMPANYc8967fba-6c28-494b-e053-2995a90acbba2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefLIDOCAINEWALGREEN COMPANYd5067903-c559-dc6d-e053-2995a90a8ee32024-10-14WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFMeijer Distribution Inc18998e1c-1254-4d0c-93f1-26652c5ca0762024-10-14WarningsExact identifier
application number: M017
signature care itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATESafeway3eedcd9f-8312-4d14-a0fe-6b00a00d3e732024-10-13WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEH E B34c7bcd3-203f-4630-894d-3739a1576c8d2024-10-13WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B25ec9014-64c4-44df-9e67-9f9223ffc9232024-10-12WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f02fa9c0-b8af-f362-e053-2a95a90ae5162024-10-11WarningsExact identifier
application number: M017
Insect Sting Relief PadBENZOCAINE, ALCOHOLHubei Changjian Medical Products Co., Ltd.6a269982-0e25-4c09-aef1-0b398bdc5ed42024-10-11WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC24221805-e5c9-5785-e063-6394a90a9d2f2024-10-10WarningsExact identifier
application number: M017
De La Cruz CamphorCAMPHORDLC Laboratories, Inc.62359237-de2d-4497-bfd6-36991cfc8acf2024-10-10WarningsExact identifier
application number: M017
Anti ItchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMeijer Distribution Inc4f536a86-6419-4ab0-a7e8-5c37943823e22024-10-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN5999b677-63dd-49c6-b5b8-7b3c117ecc5c1
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD5999b677-63dd-49c6-b5b8-7b3c117ecc5c1
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY5999b677-63dd-49c6-b5b8-7b3c117ecc5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71101-014-01711010014011 TUBE in 1 CARTON (71101-014-01) / 35.4 g in 1 TUBE1 tube2025-10-01NoNoCurrent