Dr. Sheffield Anti Itch Cream

Product NDC: 11527-069
11-digit product format: 115270069
Labeler code: 11527
Product ID: 11527-069_36f56c5a-15fe-4243-83a4-e9a54eca9a13
Type: HUMAN OTC DRUG
Nonproprietary name: Anti Itch Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Sheffield Pharmaceuticals LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-11-11
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: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	11527-069-04	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	11527-069-04	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	11527-069-04	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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: Dr. Sheffield Anti Itch Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	20 mg/g
ZINC ACETATE	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup
FM5526K07A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1087026	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
77f0593e-f694-4c02-9fd9-ad56ff2a920c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11527-069-04	2021-11-24	C162847	48780-1	9d75b9d0-585d-f424-e053-dadaa90a57ce	Sheffield Extra Strength Anti- Itch Cream
11527-069-04	2020-01-31	C162847	48780-1	9d75b9d0-585d-f424-e053-dadaa90a57ce	Sheffield Extra Strength Anti- Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11527-069-04	Dr. Sheffield Anti Itch Cream	35 g in 1 TUBE	CREAM	35		3
11527-069-04	Dr. Sheffield Anti Itch Cream	1 in 1 CARTON	CREAM	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11527-069-04	GM - Gram	11527-069	43a1f25b-33f7-4fd3-b5cf-f4abb6578be4	1	2021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
ZINC ACETATE	ACTIVE INGREDIENT	FM5526K07A	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
PEG-20 STEARATE	INACTIVE INGREDIENT	NBX892EA57	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11527-069	DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [SHEFFIELD PHARMACEUTICALS LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231031_77f0593e-f694-4c02-9fd9-ad56ff2a920c.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 60 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Honest Eczema Balm	COLLOIDAL OATMEAL	The Honest Company, Inc.	35b8bc5c-420e-4d31-9659-f36cabbd897a	2024-05-14	Warnings	Exact identifier application number: M016
Extra Strength Itch Stopping	ITCH STOPPING CREAM	Universal Distribution Centre LLC	b9a42aa3-1903-76f0-e053-2a95a90a51d1	2024-05-13	Warnings	Exact identifier application number: M016
Calamine Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Cardinal Health, 110 dba Leader	7f733c0a-82b2-d3b0-e053-2991aa0a6b0f	2024-05-13	Warnings	Exact identifier application number: M016
Walgreens Maximum Diaper Rash	ZINC OXIDE	Walgreens Company	5eb2152f-6fa2-4191-878a-207416e69818	2024-05-07	Warnings	Exact identifier application number: M016
Cetaphil Eczema Rapid Relief Cream	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	02a405fa-8ae9-41e9-b86f-ef5fb6e3844a	2024-05-02	Warnings	Exact identifier application number: M016
Chapstick	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	0e34fc74-772e-48fd-a353-58807ef412c1	2024-05-01	Warnings	Exact identifier application number: M016
Diaper Rash Cream 40% ZINC	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	16da985a-6210-ec82-e063-6294a90a132d	2024-04-24	Warnings	Exact identifier application number: M016
Petrolatum Jelly	PETROLATUM	ASTONEA LABS PRIVATE LIMITED	16dac8e5-aeb8-592d-e063-6394a90ae2b6	2024-04-24	Warnings	Exact identifier application number: M016
Monistat Complete Care Chafing Relief	DIMETHICONE	Insight Pharmaceuticals LLC	07d7c883-1fa3-4786-905c-a1fab649765e	2024-04-19	Warnings	Exact identifier application number: M016
zinc oxide 20%	ZINC OXIDE 20%	Bionpharma Inc	1549500a-0941-0fba-e063-6394a90a564e	2024-04-18	Warnings	Exact identifier application number: M016
ARC Skin Protectant	ALLANTOIN	Anjon Biologics, Inc	f4ff79dd-cb38-4cca-9631-a2758a171873	2024-04-18	Warnings	Exact identifier application number: M016
Zinctral	ZINC OXIDE	PureTek Corporation	de990834-00da-0c7a-e053-2995a90a7c37	2024-04-15	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Variety Pack	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	bfb9a2d5-1ad2-45b8-a215-9d1370af5337	2024-04-12	Warnings	Exact identifier application number: M016
ChapStick Classic Spearmint	PETROLATUM	Haleon US Holdings LLC	d39786e8-bcd8-479d-8990-142a21788a47	2024-04-12	Warnings	Exact identifier application number: M016
Chapstick 12 Days of Christmas	WHITE PETROLATUM	Haleon US Holdings LLC	d6eb2ea6-27c7-40a6-a1f0-789ea2131de3	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick Active 2in1 Variety Pack	ZINC OXIDE	Haleon US Holdings LLC	d1998a9e-d61f-4b4c-91b0-5e66754bcc4a	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick 12 Days of Christmas	WHITE PETROLATUM	Haleon US Holdings LLC	040694f0-b5ba-4203-bde9-699fa9b1afef	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick Holiday Classics Kit	WHITE PETROLATUM	Haleon US Holdings LLC	6df216dc-c03d-463a-8029-5e54c1dc3d27	2024-04-11	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula	OCTINOXATE, OXYBENZONE, WHITE PETROLATUM	Carma Laboratories, Inc.	3eb0f8ff-89e7-4410-8573-3349e4946548	2024-04-02	Warnings	Exact identifier application number: M016
Pure Cornstarch Baby	CORN STARCH	Walgreen Company	d0e9bd13-b568-4f7e-b036-8d23e71ad8bf	2024-03-25	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
FM5526K07A	ZINC ACETATE	5970-45-6	ZINC ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1087026	diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream	PSN	77f0593e-f694-4c02-9fd9-ad56ff2a920c	3
1087026	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	77f0593e-f694-4c02-9fd9-ad56ff2a920c	3
1087026	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream	SY	77f0593e-f694-4c02-9fd9-ad56ff2a920c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11527-069-04	11527006904	1 TUBE in 1 CARTON (11527-069-04) / 35 g in 1 TUBE	1 tube	2008-11-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sheffield Extra Strength Anti- Itch Cream	Sheffield Pharmaceuticals LLC	2023-10-30	HUMAN OTC DRUG LABEL	3