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 67 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
calahist	CALAMINE AND PRAMOXINE HYDROCHLORIDE	WALGREEN COMPANY	fed45e06-cc53-fbc5-e053-6294a90a1b19	2023-10-27	Warnings	Exact identifier application number: M016
calahist clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	WALGREEN COMPANY	fed469c2-fe13-6726-e053-6394a90a5f51	2023-10-27	Warnings	Exact identifier application number: M016
Dr. Sayman Salve	SALVE	Sheffield Pharmaceuticals LLC	18bdcd0c-9c81-47e1-ae24-2239ff8fd066	2023-10-24	Warnings	Exact identifier application number: M016
Theriac Advanced Healing	LANOLIN	Sheffield Pharmaceuticals LLC	c780cd27-dc9e-45f3-97f0-e59b1b6b955a	2023-10-24	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	d66e369e-9b19-b084-e053-2995a90aa259	2023-10-23	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Healing	COLLOIDAL OATMEAL	Babo Botanicals, Inc.	08659a5c-2d10-2f98-e063-6394a90a7760	2023-10-23	Warnings	Exact identifier application number: M016
White Rose Petroleum Jelly	PETROLATUM	J. Strickland & Co.	1aeb090d-c103-4c2e-accc-d9d248315db9	2023-10-21	Warnings	Exact identifier application number: M016
Tricalm Hydrogel	ALUMINUM ACETATE	MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES	082c6441-be47-4466-e063-6394a90ad500	2023-10-20	Warnings	Exact identifier application number: M016
Empower	WHITE PETROLATUM, ZINC OXIDE	Bemis Manufacturing Company Inc	08006b60-966b-155b-e063-6294a90a206a	2023-10-18	Warnings	Exact identifier application number: M016
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier application number: M016
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier application number: M016
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE, ZIRHAFIRM	ANUBIS COSMETICS SL	f2274f8c-08aa-eb02-e053-2a95a90a3998	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES	ANUBIS COSMETICS SL	ebe024f7-7c45-ad60-e053-2995a90a45d6	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL	ANUBIS COSMETICS SL	ebdddcec-f5da-51fe-e053-2995a90a6167	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE	ANUBIS COSMETICS SL	eb53cba1-0509-43bc-e053-2995a90a5e09	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	FERULIC ACID, VITAMIN C, DMAE	ANUBIS COSMETICS SL	eaf0770c-795d-0232-e053-2a95a90ae0b5	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	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