Lemon

Product NDC: 68786-160
11-digit product format: 687860160
Labeler code: 68786
Product ID: 68786-160_47e7cac8-63df-eced-e063-6394a90a9ba3
Type: HUMAN OTC DRUG
Nonproprietary name: Glycerin
Dosage form: SWAB
Route: ORAL
Labeler: Sion Biotext Medical Ltd
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-04-11
Substance: GLYCERIN
Active strength: 7.5 mg/100mg
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 12 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
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	68786-160-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68786-160-02	`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	68786-160-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68786-160-02	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68786-160-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68786-160-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68786-160-01	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68786-160-02	`9bebd1f3094a…`	`5416666fcb17…`

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: Lemon
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCERIN	7.5 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PDC6A3C0OX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1114098	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
dbd7ed86-1b92-4471-827a-89f3afa1b0dc	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68786-160-01	2024-05-16	Lemon Glycerin Swabsticks
68786-160-01	2024-05-16	Lemon Glycerin Swabsticks
68786-160-02	2024-05-16	Lemon Glycerin Swabsticks
68786-160-02	2024-05-16	Lemon Glycerin Swabsticks
68786-160-01	2024-01-30	Lemon Glycerin Swabsticks
68786-160-01	2024-01-30	Lemon Glycerin Swabsticks
68786-160-02	2024-01-30	Lemon Glycerin Swabsticks
68786-160-02	2024-01-30	Lemon Glycerin Swabsticks
68786-160-01	2021-01-12	Lemon Glycerin Swabsticks
68786-160-01	2021-01-12	Lemon Glycerin Swabsticks
68786-160-02	2021-01-12	Lemon Glycerin Swabsticks
68786-160-02	2021-01-12	Lemon Glycerin Swabsticks
68786-160-01	2020-01-31	Lemon Glycerin Swabsticks
68786-160-01	2020-01-31	Lemon Glycerin Swabsticks
68786-160-02	2020-01-31	Lemon Glycerin Swabsticks
68786-160-02	2020-01-31	Lemon Glycerin Swabsticks

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68786-160-01	Lemon	10 in 1 CASE	SWAB	10	7
68786-160-01	Lemon	50 in 1 BOX	SWAB	50	7
68786-160-02	Lemon	10 in 1 CASE	SWAB	10	7
68786-160-02	Lemon	25 in 1 BOX	SWAB	25	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYCERIN	ACTIVE INGREDIENT	PDC6A3C0OX	LEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]	1
GLYCERIN	ACTIVE MOIETY	PDC6A3C0OX	LEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	LEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	LEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68786-160	LEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]	6	Current NDC, Legacy NDC, 4 package rows	20240517_dbd7ed86-1b92-4471-827a-89f3afa1b0dc.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 7 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lemon Glycerin	GLYCERIN	Dynarex Corporation	99fc00ea-9d55-0380-e053-2995a90a2c0b	2026-03-24	Warnings	Exact identifier application number: M022
Dual-FormulaToothpaste for sensitive teeth	DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH	Hangzhou Namei Zhikang Technology Co., Ltd.	4d735f91-8abc-3a30-e063-6394a90a7639	2026-03-20	Warnings	Exact identifier application number: M022
SmileCare Mouth Ulcer Gel	MENTHOL	Yantai Aien Biotechnology Co., Ltd.	4d6db039-5b97-8f3f-e063-6294a90a9d85	2026-03-19	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f91e609-8ca5-0492-e053-2a95a90a85d0	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f81ffa5-05fd-4eef-e053-2995a90aac3e	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947366-9380-3fa9-e053-2a95a90ad49c	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947672-4873-5546-e053-2a95a90a3c4b	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f9490c1-8bfe-3166-e053-2a95a90a7175	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f94b65d-47e3-9c6b-e053-2a95a90aa1f8	2026-03-17	Warnings	Exact identifier application number: M022
BencoCaine Topical Anesthetic	BENZOCAINE	Benco Dental	4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b	2026-03-17	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043c00a6-1346-7780-e063-6294a90a3d5a	2026-03-12	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Nantong Health & Beyond Hygienic Products Inc.	a5f0be98-d47e-4307-8044-304a64db774b	2026-03-11	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	a2f9d58b-671b-4427-a971-1fceff5f2323	2026-03-09	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	CVS Pharmacy, Inc.	a5dbaadf-76a8-4c48-af2d-f4455e9411f0	2026-03-09	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Sam's West, Inc	78a3e024-73da-40b7-9d9c-099fd6ca9b9e	2026-03-03	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL GLYCERIN	CVS PHARMACY, INC	9683bcfb-2f7e-48a4-aa79-500ee8df099a	2026-03-02	Warnings	Exact identifier application number: M022
Spring Gene Oil Pulling Sensitivity	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	294051e3-69ec-4190-8b03-fa34988376b7	2026-02-26	Warnings	Exact identifier application number: M022
Lolleez Watermelon	PECTIN	BFY LLC	4ba8af8b-5a17-8b8c-e063-6394a90a63f3	2026-02-25	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	H E B	f1450866-1be4-46d9-9fe4-52d699636b4f	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M022
SIGNATURE CARE SORE THROAT CHERRY FLAVOR	PHENOL	SAFEWAY	94a2c1b9-f462-4489-b84a-825a82835d30	2026-02-23	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1114098	glycerin 7.5 % Medicated Pad	PSN	dbd7ed86-1b92-4471-827a-89f3afa1b0dc	7
1114098	glycerin 75 MG/ML Medicated Pad	SCD	dbd7ed86-1b92-4471-827a-89f3afa1b0dc	7
1114098	glycerin 7.5 % Medicated Swab	SY	dbd7ed86-1b92-4471-827a-89f3afa1b0dc	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68786-160-01	68786016001	10 BOX in 1 CASE (68786-160-01) / 50 PACKET in 1 BOX / 1 mg in 1 PACKET	10 box	2013-04-11	0000-00-00	No	No	Current
68786-160-02	68786016002	10 BOX in 1 CASE (68786-160-02) / 25 PACKET in 1 BOX / 3 mg in 1 PACKET	10 box	2013-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lemon Glycerin Swabsticks	Sion Biotext Medical Ltd \| Sion Biotext Mexico SAPI de CV	2026-01-08	HUMAN OTC DRUG LABEL	7