FDA.reportPublic FDA data

GNP Extra Strength Anti-Itch Cream

Product NDC
46122-804
11-digit product format
461220804
Labeler code
46122
Product ID
46122-804_34a66224-ef3d-e36e-e063-6394a90ac99d
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride, Zinc acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Amerisource Bergen
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
Substance
ZINC ACETATE; DIPHENHYDRAMINE HCL
Active strength
.1; 2 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
2026-12-31
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
GNP Extra Strength Anti-Itch Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC ACETATE.1 g/100g
DIPHENHYDRAMINE HCL2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FM5526K07AInternal UNII lookup
TC2D6JAD40Internal 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
34a66224-ef3c-e36e-e063-6394a90ac99dAvailable 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
46122-804-36GNP Extra Strength Anti-Itch Cream1 g in 1 TUBECREAM11
46122-804-36GNP Extra Strength Anti-Itch Cream1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-804-36GM - Gram46122-8042ee9ec29-d2ab-4d4d-a8af-4903dfc1bc3912025-08-11

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 135 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ralli Rapid Pain Relief Roll onMENTHOLTroy Manufacturing, Inc.978d5c2c-fdc4-4d25-83ec-0b9404ec80182024-02-19WarningsExact identifier
application number: M017
11681168 BURN SPRAYDynarex Corporation1183a4f5-f875-dfb0-e063-6394a90af35f2024-02-16WarningsExact identifier
application number: M017
Pain ReliefBENZOCAINESafetec of America, Inc.de84e598-d047-4fae-b2ed-155a3788bc6f2024-02-16WarningsExact identifier
application number: M017
No Mess Hydrocortisone ApplicatorHYDROCORTISONEWalgreen Co.cfefb517-9099-41c4-8a95-74414ca4032c2024-02-16WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpab9bf09d-bc8c-6d17-e053-2995a90a6c362024-02-14WarningsExact identifier
application number: M017
Natures Oil 16% MentholMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.2fbe23b7-23a3-4f0b-bc08-0205256f5d682024-02-14WarningsExact identifier
application number: M017
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATERugby Laboratories4c11876c-57ec-4429-a8c4-fb95baa4074a2024-02-13WarningsExact identifier
application number: M017
Itch stopping CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.11368823-d4af-a536-e063-6294a90a7a2e2024-02-12WarningsExact identifier
application number: M017
Walgreens Boil Pain ReliefBOIL PAIN RELIEFWalgreens Companyd11bd769-68d0-4057-bc2a-72719f16011e2024-02-12WarningsExact identifier
application number: M017
CapsaicinCAPSAICINRugby Laboratoriesc5915c84-84a2-46f6-9f97-0d9873e9944a2024-02-12WarningsExact identifier
application number: M017
Leader Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADER952e56ea-5cbc-4078-bd01-5d3b6864a5ce2024-02-09WarningsExact identifier
application number: M017
Leader Ultra Strength Muscle Rub Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATECardinal Health, 110 dba LEADER9d99a900-60e0-454c-98e0-2c63eb910cf12024-02-09WarningsExact identifier
application number: M017
Pain RelievingCAMPHOR (NATURAL)J.R. Watkins, LLC.28821ffa-a138-47b5-8857-beadf7a20d432024-02-08WarningsExact identifier
application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic RubCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.fd0ea70a-ef12-48b1-8d9d-cc5f6417f8542024-02-08WarningsExact identifier
application number: M017
Pain Relieving CoolingMENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.3574d48a-b546-4ea7-b470-071bb328de642024-02-08WarningsExact identifier
application number: M017
Advil Targeted ReliefCAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATEHaleon US Holdings LLC16e6be21-7b43-443a-89ec-3bdf0ec0dfc12024-02-08WarningsExact identifier
application number: M017
POINT RELIEF COLD SPOT Pain RelievingMENTHOLFABRICATION ENTERPRISES96f1d592-6cec-412e-a5fd-cf3c4f68644f2024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.1c5eb3b3-79b3-472a-ae36-ec6a7dc729252024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
application number: M017
Nova Natura Topical AnalgesicCAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATESEYITLER KIMYA SANAYI ANONIM SIRKETIabf00f73-f0b1-439e-85aa-bbce8a1ec9202024-02-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN34a66224-ef3c-e36e-e063-6394a90ac99d1
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD34a66224-ef3c-e36e-e063-6394a90ac99d1
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY34a66224-ef3c-e36e-e063-6394a90ac99d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-804-36461220804361 TUBE in 1 CARTON (46122-804-36) / 1 g in 1 TUBE1 tube2025-06-01NoNoCurrent