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 19 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	Perrigo Direct, Inc	256bd1d4-fd50-408f-9aee-84f218bb4971	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Perrigo Direct, Inc	e11470b2-80d6-4008-b87e-eb6aeadfce74	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Perrigo Direct, Inc	cc0378f2-6d5f-47ec-b16a-64668b4c29cc	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXIND HCL	Perrigo Direct, Inc	54a20ec9-ab86-4410-af94-e04393e9d4b3	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Meijer, Inc.	adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Meijer, Inc.	1b72f927-c2ae-4190-a035-5d7bb9f53c15	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Meijer, Inc.	af293cc0-ccd5-42a6-861b-c19fa6ffd06a	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing for Babies	PETROLATUM	Meijer, Inc.	09878fe0-0890-4af3-a3f6-d2890041e9f8	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Meijer, Inc.	fa8ae34c-7b68-454f-8a3b-0eaa93a34092	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Diaper Rash	ZINC OXIDE	Meijer, Inc.	04bec667-a11e-42d2-a4b3-1416eebf1e8d	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Meijer, Inc.	8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Meijer, Inc.	6b369ef2-fd54-4931-a9eb-0fb42834c2ef	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Meijer, Inc.	75b91b97-ea84-4c4d-9e58-5a9ff27a778c	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Meijer, Inc.	d36a7479-7b3b-49fe-8144-b5cce0e173fb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DAILY MOISTURIZING	Meijer, Inc.	44949b46-70f2-4e52-adba-a8455da614eb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Meijer, Inc.	13e4aece-5b91-4f89-a912-540bf170a8d1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Target Corporation	7fb5f9ca-cd90-4933-9fe8-907ece00458b	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Target Corporation	d4ee05c8-ae62-45df-8783-1ed57fa030ec	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Target Corporation	5237c7f2-7135-4558-a758-4fc2a232172f	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Target Corporation	3e620e4f-9e29-9e39-e063-6394a90adeda	2026-02-18	Warnings, Adverse reactions	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