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 31 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oral Gel Oral Pain Relief	BENZOCAINE BENZALKONIUM CHLORIDE	Savvy Care and Cosmetics	05ede7e4-5a0a-c942-e063-6294a90a8a24	2024-12-19	Warnings	Exact identifier application number: M022
EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint	SODIUM BICARBONATE	Lotus Brands, Inc.	4a95c8c1-db7c-4791-ac58-3eac216a0126	2024-12-18	Warnings	Exact identifier application number: M022
EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon	SODIUM BICARBONATE	Lotus Brands, Inc.	6703b29d-cdc9-4c74-91c0-fb0c98dd043e	2024-12-18	Warnings	Exact identifier application number: M022
Red Cross Oral Pain Relief	BENZOCAINE	The Mentholatum Company	cbd41429-f730-4577-9f06-ef1831cf62e1	2024-12-17	Warnings	Exact identifier application number: M022
Red Cross Canker Sore	BENZOCAINE	The Mentholatum Company	54cfff96-6665-4b36-a15d-10bf6cf3a1f9	2024-12-17	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	116956644	2981217f-f250-c090-e063-6294a90a85b0	2024-12-17	Warnings	Exact identifier application number: M022
Kank-A Mouth Pain	BENZOCAINE	Blistex Inc.	eebc03ba-f849-4e70-a653-834f383b6aa4	2024-12-17	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	8282a4a6-b77c-75fc-e053-2991aa0ad4ac	2024-12-16	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories,Inc.	9452bff4-8c08-eff9-e053-2a95a90a67ed	2024-12-16	Warnings	Exact identifier application number: M022
PHENOL	PHENOL	CHAIN DRUG MARKETING ASSOCIATION INC.	2379e23a-72fe-4e94-9d7e-9b623c0db174	2024-12-13	Warnings	Exact identifier application number: M022
KANKA SoftBrush	BENZOCAINE AND ZINC CHLORIDE	Blistex Inc	093f3545-1d8e-48a3-a533-e9c3ae6d740b	2024-12-12	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	826eaef8-4457-3dc2-e053-2991aa0a528b	2024-12-11	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	8281700c-10f9-841c-e053-2991aa0a918f	2024-12-11	Warnings	Exact identifier application number: M022
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	82824416-80de-76bd-e053-2a91aa0ad8b5	2024-12-11	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories,Inc.	e3da0e63-a891-72bd-e053-2a95a90a58bc	2024-12-11	Warnings	Exact identifier application number: M022
Topicale Xtra	BENZOCAINE	Medical Products Laboratories, Inc.	e3d924b5-0788-46d3-e053-2995a90a027b	2024-12-11	Warnings	Exact identifier application number: M022
Fluoride Bits	SODIUM MONOFLUOROPHOSPHATE 0.76%	The Kind Lab, Inc.	fa433031-7376-0e5b-e053-6394a90a5f75	2024-12-11	Warnings	Exact identifier application number: M022
Fluoride Bits	SODIUM MONOFLUOROPHOSPHATE 0.76%	The Kind Lab, Inc.	eedf13dc-a009-027a-e053-2995a90a8ec8	2024-12-11	Warnings	Exact identifier application number: M022
NATURAL LEMON MINT HERB THROAT DROPS	MENTHOL	Ricola USA Inc.	763e8234-60be-4b1f-9f78-01c574f35d0a	2024-12-10	Warnings	Exact identifier application number: M022
Natural Cherry Honey Herb Throat Drops	MENTHOL	Ricola USA Inc.	989f8509-cd28-48e7-9aa1-baddfbcac95a	2024-12-10	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