PEDIADERMICS ECZEMA 2

Product NDC: 76348-585
11-digit product format: 763480585
Labeler code: 76348
Product ID: 76348-585_44fb0779-2a64-f2a5-e063-6294a90a33d1
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: SPRAY
Route: TOPICAL
Labeler: RENU LABORATORIES, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-03-18
Substance: HYDROCORTISONE
Active strength: 1.12 g/112g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 · 14 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
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76348-585-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76348-585-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76348-585-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76348-585-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76348-585-04	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76348-585-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76348-585-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: PEDIADERMICS ECZEMA 2
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	1.12 g/112g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
317564	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
da840bf6-ed65-bafc-e053-2a95a90a92d5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-585-04	2025-04-18	C162847	48780-1	2cef2736-6249-d83d-e063-dadaa90ab31f	PEDIADERMICS ECZEMA 2
76348-585-04	2025-01-30	C162847	48780-1	2cef2736-6249-d83d-e063-dadaa90ab31f	PEDIADERMICS ECZEMA 2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-585-04	PEDIADERMICS ECZEMA 2	112 g in 1 BOTTLE, SPRAY	SPRAY	112		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-585	PEDIADERMICS ECZEMA 2 (HYDROCORTISONE) SPRAY [RENU LABORATORIES, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20250419_da840bf6-ed65-bafc-e053-2a95a90a92d5.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 121 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Maximum Strength Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Topco Associates LLC	dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Restorative Skin Therapy Itch Relief Balm	PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	61824ca7-a2d3-4830-b2bb-149a3222bfc8	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Hydrocortisone ANTI-ITCH	HYDROCORTISONE	Kenvue Brands LLC	233de4d7-e533-40cd-a5ed-e8b09abc626e	2024-11-05	Warnings	Exact identifier application number: M017
STING MASTER	LIDOCAINE HYDROCHLORIDE	Les Technologies Ptero, Inc	94c6fd1f-9e74-420b-9d25-61b37953b838	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a35ac19-6883-a733-e063-6294a90ad22d	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Plus	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products, Inc.	cfe8114b-df65-064b-e053-2a95a90a33f6	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Botanicals	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	02a8e5c7-56f4-eb0d-e063-6294a90a80cd	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn Pads	LIDOCAINE HYDROCHLORIDE	Quest Products, Inc.	fe58bb89-7216-4121-afd3-d1438bdfbfa2	2024-11-05	Warnings	Exact identifier application number: M017
Licefreee AfterLice	PRAMOXINE HCI	Tec Laboratories Inc.	06c4cc42-a215-3949-e063-6394a90a665e	2024-11-05	Warnings	Exact identifier application number: M017
Antibacterial Lidocaine Wound Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	ASO LLC	cb9505b7-222d-3a24-e053-2a95a90a0b64	2024-11-05	Warnings	Exact identifier application number: M017
TopCare Pain Relieving Analgesic	LIDOCAINE HYDROCHLORIDE	Topco Associates LLC	6b4783e0-1987-4838-9e8c-b95426d62b28	2024-11-05	Warnings	Exact identifier application number: M017
Eagle Green Balm	CAMPHOR MENTHOL	Borden Company (Private) Limited	6f7a796b-a31c-0e60-e053-2a91aa0a022b	2024-11-04	Warnings	Exact identifier application number: M017
Muscular Balm	CAPSAICIN MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	ed79f14e-6b3d-4bf2-9c34-d019c1ba2582	2024-11-04	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	A-S Medication Solutions	3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3	2024-11-04	Warnings	Exact identifier application number: M017
Walgreens Ice Blue Pain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Walgreen Company	1c0ee442-ffd2-4f6c-aab2-f70e295378ad	2024-11-04	Warnings	Exact identifier application number: M017
Walgreen Cool n Heat Maximum Strength Pain Relieving	MENTHOL, UNSPECIFIED FORM	Walgreen Company	d5c79476-dde8-4a85-8878-bc2ac3a3d70b	2024-11-04	Warnings	Exact identifier application number: M017
LIDOCAINE	LIDOCAINE	STRATUS PHARMACEUTICALS INC	87a4f559-a4f6-4b9f-98de-b55b073a11c6	2024-11-01	Warnings	Exact identifier application number: M017
Walgreens Nerve Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM	Walgreen Company	83849eca-e02f-4b43-b3a7-b25e987e08a8	2024-10-31	Warnings	Exact identifier application number: M017
Sanar Naturals Arnica White	CAMPHOR	Sanvall Enterprises, Inc	192039a2-aed6-821b-e063-6394a90a7f29	2024-10-31	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
317564	hydrocortisone 1 % Topical Spray	PSN	da840bf6-ed65-bafc-e053-2a95a90a92d5	3
317564	hydrocortisone 10 MG/ML Topical Spray	SCD	da840bf6-ed65-bafc-e053-2a95a90a92d5	3
317564	hydrocortisone 1 % Topical Spray	SY	da840bf6-ed65-bafc-e053-2a95a90a92d5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76348-585-04	76348058504	112 g in 1 BOTTLE, SPRAY (76348-585-04)	112 g	2022-03-18	0000-00-00	No	No	Current