Bikini Zone Medicated CREME

Product NDC: 61543-1601
11-digit product format: 615431601
Labeler code: 61543
Product ID: 61543-1601_eff14d9c-3c24-2f9d-e053-2995a90a3846
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE
Dosage form: CREAM
Route: TOPICAL
Labeler: CCA Industries, Inc.
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-06-03
Marketing end: 0000-00-00
Substance: LIDOCAINE
Active strength: 2 g/100g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61543-1601		I	Inactivated by FDA		2026-08-17
excluded package	package	61543-1601	61543-1601-1	I	Inactivated by FDA		2026-08-17

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61543-1601-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61543-1601-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61543-1601-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61543-1601-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61543-1601-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61543-1601-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61543-1601-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61543-1601-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61543-1601-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61543-1601-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61543-1601-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61543-1601-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61543-1601-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61543-1601-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61543-1601-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61543-1601-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61543-1601-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61543-1601-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61543-1601-1	`8dfbde2a14a4…`	`c9ff85d89658…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	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
61543-1601-1	2024-01-30	C162847	48780-1	ba0f9c33-1078-a910-e053-dadaa90a0b85	Bikini Zone Medicated CREME
61543-1601-1	2022-12-16	C162847	48780-1	ba0f9c33-1078-a910-e053-dadaa90a0b85	Bikini Zone Medicated CREME
61543-1601-1	2021-01-29	C162847	48780-1	ba0f9c33-1078-a910-e053-dadaa90a0b85	Bikini Zone Medicated CREME

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61543-1601-1	Bikini Zone Medicated CREME	1 in 1 BOX	CREAM	1		7
61543-1601-1	Bikini Zone Medicated CREME	28 g in 1 TUBE	CREAM	28		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
LIDOCAINE	ACTIVE MOIETY	98PI200987	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
PROPYLENE GLYCOL DICAPRYLATE	INACTIVE INGREDIENT	581437HWX2	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61543-1601	BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]	7	Legacy NDC, 2 package rows	20221217_091169e6-5021-431e-ab68-8c10e4f8f0c5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106222	lidocaine 2 % Topical Cream	PSN	091169e6-5021-431e-ab68-8c10e4f8f0c5	7
106222	lidocaine 20 MG/ML Topical Cream	SCD	091169e6-5021-431e-ab68-8c10e4f8f0c5	7
106222	lidocaine 2 % Topical Cream	SY	091169e6-5021-431e-ab68-8c10e4f8f0c5	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61543-1601-1	61543160101	1 TUBE in 1 BOX (61543-1601-1) > 28 g in 1 TUBE	1 tube	2019-03-15	0000-00-00	No	No	Current