pain relief roll-on

Product NDC: 69452-393
11-digit product format: 694520393
Labeler code: 69452
Product ID: 69452-393_29f92d33-ff52-1181-e063-6394a90a6211
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine 4%
Dosage form: LIQUID
Route: TOPICAL
Labeler: Bionpharma Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-02-20
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 4 g/100mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: pain relief roll-on
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1987647	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
f607b6dc-8d13-604a-e053-2995a90a59ab	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69452-393-63	pain relief roll-on	74 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	74		2
69452-393-63	pain relief roll-on	1 in 1 CARTON	LIQUID	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-393	PAIN RELIEF ROLL-ON (LIDOCAINE 4%) LIQUID [BIONPHARMA INC.]	2	Current NDC, 2 package rows	20241225_f607b6dc-8d13-604a-e053-2995a90a59ab.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 128 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AOSI HEALTHCARE BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	a28b920c-0bb8-4b5a-addd-26ea164e036e	2024-09-25	Warnings	Exact identifier application number: M017
anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Kroger Company	067e718a-ec0b-4895-8f9f-82d64ab4c7b4	2024-09-24	Warnings	Exact identifier application number: M017
topcare anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Topco Associates LLC	e0fb332a-2903-41ef-b35b-7cd3a74cff99	2024-09-24	Warnings	Exact identifier application number: M017
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	83cd9f60-a4c4-4dea-97a7-cd96aade9e88	2024-09-24	Warnings	Exact identifier application number: M017
good sense itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	L. Perrigo Company	162fe0a3-3995-4e6f-94ed-f839b2b0c80e	2024-09-24	Warnings	Exact identifier application number: M017
Caring Mill Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Veridian Healthcare	22ca137a-576c-a13c-e063-6394a90ae7fc	2024-09-23	Warnings	Exact identifier application number: M017
Signature Care Anti Itch	HYDROCORTISONE	Safeway	ed0eb068-3ce6-423d-a7f8-c3456b7f6040	2024-09-23	Warnings	Exact identifier application number: M017
members mark hydrocortisone	HYDROCORTISONE	Sam's West Inc	218f0dcd-fa67-4935-8019-ecbbd53ed2f7	2024-09-23	Warnings	Exact identifier application number: M017
anti itch	HYDROCORTISONE	Meijer, Inc.	a07496e0-6fc2-4190-8a01-f513134ffb92	2024-09-23	Warnings	Exact identifier application number: M017
ZYLOTROL PAIN RELIEVING	LIDOCAINE HCL, MENTHOL	Whitestone Products LLC	2301fed7-0fa9-450d-8b1b-006f53235be0	2024-09-21	Warnings	Exact identifier application number: M017
Tibetree Cheezheng Joint Analgesic Patch	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd	65a8a63f-1864-473e-be72-7840a6a5dee7	2024-09-20	Warnings	Exact identifier application number: M017
Cold Ice Analgesic Gel	MENTHOL	Dabur India Limited	22915b2f-5f76-3e38-e063-6394a90a07b4	2024-09-20	Warnings	Exact identifier application number: M017
Exchange Select Hydrocortisone	HYDROCORTISONE	Army & Air Force Exchange Service	1b709db3-7dc1-4756-a8a0-dddda875dc57	2024-09-19	Warnings	Exact identifier application number: M017
Theraworx PM Nighttime Maximum Strength Pain Relief	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	bc8cb476-9a47-47b3-ad78-a6ecec9ee66f	2024-09-19	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Stratus Pharmaceuticals Inc	e1a8d4a7-01f7-4bab-8d09-875c461b3b61	2024-09-19	Warnings	Exact identifier application number: M017
Camphor Spirit	CAMPHOR 10%	Strategic Sourcing Services, LLC	2216d799-7f6f-cab7-e063-6294a90a8d6c	2024-09-14	Warnings	Exact identifier application number: M017
Meijer Analgesic Lidocaine Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa	2024-09-12	Warnings	Exact identifier application number: M017
leader anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Cardinal Health 110, LLC. dba Leader	e1aab35b-80d9-4515-afb7-8c662bc5d028	2024-09-11	Warnings	Exact identifier application number: M017
LactiGo	MENTHOL	LactiGo, Inc.	849c3601-2bc8-0991-e053-2a91aa0a5e7f	2024-09-03	Warnings	Exact identifier application number: M017
Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis	MENTHOL 8%	Telebrands Corp	c22cf1a5-0d5d-5ea5-e053-2995a90a333b	2024-09-02	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1987647	lidocaine hydrochloride 4 % Topical Solution	PSN	f607b6dc-8d13-604a-e053-2995a90a59ab	2
1987647	lidocaine hydrochloride 40 MG/ML Topical Solution	SCD	f607b6dc-8d13-604a-e053-2995a90a59ab	2
1987647	lidocaine hydrochloride 4 % Topical Solution	SY	f607b6dc-8d13-604a-e053-2995a90a59ab	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69452-393-63	69452039363	1 BOTTLE, WITH APPLICATOR in 1 CARTON (69452-393-63) / 74 mL in 1 BOTTLE, WITH APPLICATOR	2023-02-20	No	No	Current