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 21 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry	FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	3573f149-2af9-4c86-e063-6294a90a7b3f	2025-05-18	Warnings	Exact identifier application number: M022
Bubble Gum Flavor For Kids 25g 50g	BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	354c1eda-ec5b-a8c7-e063-6294a90a871d	2025-05-16	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Safeway, Inc.	8fe2f1df-3264-455d-b62c-953dce171c02	2025-05-16	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath Freshener	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	32b632bf-058d-447b-a7fb-a9dd05c1e2b8	2025-05-08	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Clear Mint	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	444f931d-5e38-4cda-97ba-98aa0b5fe4f6	2025-05-08	Warnings	Exact identifier application number: M022
Listerine Clinical Solutions Gum Health Icy Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	06e1122b-1100-43c0-e063-6394a90a2e78	2025-04-22	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	5260258a-bb1e-43d6-bce1-70a38778a64a	2025-04-14	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	TARGET Corporation	93d0bb3a-51d3-44c8-8fb7-bdb82adfbb65	2025-04-14	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee467ec4-bd5e-644a-e053-2a95a90ac273	2025-04-10	Warnings	Exact identifier application number: M022
Mouthwash	MENTHOL, METHYL SALICYLATE, THYMOL	Orazen Inc	873c43df-1d46-359b-e053-2a91aa0a4319	2025-04-07	Warnings	Exact identifier application number: M022
Sensodyne Complete Protection Extra Fresh	STANNOUS FLUORIDE	Haleon US Holdings LLC	e3cc3146-8aed-4f6b-a252-e379418c2b8d	2025-03-26	Warnings	Exact identifier application number: M022
Listerine Freshburst Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee1e1df9-74c6-d24b-e053-2a95a90a43d3	2025-03-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	edb9e374-4dba-5823-e053-2a95a90a3da5	2025-03-03	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Good Sense (Geiss, Destin & Dunn, Inc.)	cfe9be26-e4a4-413c-a602-2f5948e3bb7a	2025-03-03	Warnings	Exact identifier application number: M022
LISTERINE Original Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	78e2e172-09a4-4bf1-9871-d099c49087be	2025-02-28	Warnings	Exact identifier application number: M022
WHITE GLO CHARCOAL SENSITIVE	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	a5edb7fd-c637-5447-e053-2995a90a5a6f	2025-02-26	Warnings	Exact identifier application number: M022
Glorysmile Toothpaste.	GLORYSMILE TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	2ef48156-904d-e42a-e063-6394a90a3cd0	2025-02-25	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Walgreens	c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa	2025-02-21	Warnings	Exact identifier application number: M022
Sheffield Pain Relief	BENZOCAINE	Sheffield Pharmaceuticals LLC	e21abfdd-373d-42af-9535-fe1571382a65	2025-02-19	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Whole Foods Market	a2bb142e-8cbe-481e-bf4f-810ca6d14591	2025-02-12	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