ATO STANDARD PREMIUM MILDCREAM

Product NDC: 81160-201
Requested package NDC: 81160-201-01
11-digit product format: 811600201
Labeler code: 81160
Product ID: 81160-201_d108b193-c9c1-0340-e053-2a95a90ad775
Type: HUMAN OTC DRUG
Nonproprietary name: BUTYROSPERMUM PARK2 SHEA BUTTER, CENTELLA ASIATICA Extract, CERAMIDE NP
Dosage form: CREAM
Route: TOPICAL
Labeler: TIMEBIO Co., Ltd
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2021-02-01
Marketing end: 0000-00-00
Substance: CENTELLA ASIATICA WHOLE; SHEA BUTTER; CERAMIDE NP
Active strength: 0 g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	81160-201	81160-201-01	I	Inactivated by FDA		2026-09-14

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81160-201-01	2023-01-30	C162847	48780-1	f386c649-c681-0266-e053-dadaa90a7c1a	81160-201 ATO STANDARD Premium Mild Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81160-201-01	ATO STANDARD PREMIUM MILDCREAM	75 g in 1 TUBE	CREAM	75		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81160-201	ATO STANDARD PREMIUM MILDCREAM (BUTYROSPERMUM PARK2 SHEA BUTTER, CENTELLA ASIATICA EXTRACT, CERAMIDE NP) CREAM [TIMEBIO CO., LTD]	3	Legacy NDC, 1 package rows	20211119_b59a75f8-df1c-1cb3-e053-2a95a90a3e55.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K49155WL9Y	SHEA BUTTER	194043-92-0	SHEA BUTTER
4370DF050B	CERAMIDE NP	100403-19-8	CERAMIDE NP

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81160-201-01	81160020101	75 g in 1 TUBE (81160-201-01)	75 g	2021-02-01	0000-00-00	No	No	Current