ACNE RELIEF CALMING TREATMENT AND HYDRATOR

Product NDC: 45634-102
Requested package NDC: 45634-102-01
11-digit product format: 456340102
Labeler code: 45634
Product ID: 45634-102_2462ceb9-4c70-4f9b-afc2-a81e352f4b2f
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid Acne Treatment
Dosage form: LOTION
Route: TOPICAL
Labeler: NV Perricone LLC
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-08-01
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 0 g/59mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	45634-102	45634-102-01	I	Inactivated by FDA		2026-10-12

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 · 16 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…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45634-102-01	2024-01-30	C162847	48780-1	ba0f9c33-5033-a910-e053-dadaa90a0b85	ACNE RELIEF CALMING TREATMENT & HYDRATOR STEP 2 - DAY
45634-102-01	2022-02-10	C162847	48780-1	ba0f9c33-5033-a910-e053-dadaa90a0b85	ACNE RELIEF CALMING TREATMENT & HYDRATOR STEP 2 - DAY
45634-102-01	2021-01-29	C162847	48780-1	ba0f9c33-5033-a910-e053-dadaa90a0b85	ACNE RELIEF CALMING TREATMENT & HYDRATOR STEP 2 - DAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45634-102-01	ACNE RELIEF CALMING TREATMENT AND HYDRATOR	59 mL in 1 BOTTLE, DROPPER	LOTION	59		2
45634-102-01	ACNE RELIEF CALMING TREATMENT AND HYDRATOR	1 in 1 PACKAGE	LOTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45634-102	ACNE RELIEF CALMING TREATMENT AND HYDRATOR (SALICYLIC ACID ACNE TREATMENT) LOTION [NV PERRICONE LLC]	2	Legacy NDC, 2 package rows	20220211_68ca7c59-afa4-4260-bc15-a7ebac372d1f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199134	salicylic acid 0.5 % Topical Lotion	PSN	68ca7c59-afa4-4260-bc15-a7ebac372d1f	2
199134	salicylic acid 5 MG/ML Topical Lotion	SCD	68ca7c59-afa4-4260-bc15-a7ebac372d1f	2
199134	salicylic acid 0.5 % Topical Lotion	SY	68ca7c59-afa4-4260-bc15-a7ebac372d1f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45634-102-01	45634010201	1 BOTTLE, DROPPER in 1 PACKAGE (45634-102-01) > 59 mL in 1 BOTTLE, DROPPER	2019-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACNE RELIEF CALMING TREATMENT & HYDRATOR STEP 2 - DAY	NV Perricone LLC	2022-02-10	HUMAN OTC DRUG LABEL	2