FDA.reportPublic FDA data

Lemon

Product NDC
68786-160
Requested package NDC
68786-160-01
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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
Lemon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN7.5 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1114098Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbd7ed86-1b92-4471-827a-89f3afa1b0dcAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68786-160-012024-05-16Lemon Glycerin Swabsticks
68786-160-012024-05-16Lemon Glycerin Swabsticks
68786-160-022024-05-16Lemon Glycerin Swabsticks
68786-160-022024-05-16Lemon Glycerin Swabsticks
68786-160-012024-01-30Lemon Glycerin Swabsticks
68786-160-012024-01-30Lemon Glycerin Swabsticks
68786-160-022024-01-30Lemon Glycerin Swabsticks
68786-160-022024-01-30Lemon Glycerin Swabsticks
68786-160-012021-01-12Lemon Glycerin Swabsticks
68786-160-012021-01-12Lemon Glycerin Swabsticks
68786-160-022021-01-12Lemon Glycerin Swabsticks
68786-160-022021-01-12Lemon Glycerin Swabsticks
68786-160-012020-01-31Lemon Glycerin Swabsticks
68786-160-012020-01-31Lemon Glycerin Swabsticks
68786-160-022020-01-31Lemon Glycerin Swabsticks
68786-160-022020-01-31Lemon Glycerin Swabsticks

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-160-01Lemon10 in 1 CASESWAB107
68786-160-01Lemon50 in 1 BOXSWAB507
68786-160-02Lemon10 in 1 CASESWAB107
68786-160-02Lemon25 in 1 BOXSWAB257

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXLEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]1
GLYCERINACTIVE MOIETYPDC6A3C0OXLEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RLEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-160LEMON (GLYCERIN) SWAB [SION BIOTEXT MEDICAL LTD]6Current NDC, Legacy NDC, 4 package rows20240517_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 1 of 42 · 822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
application number: M022
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
application number: M022
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
application number: M022
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
application number: M022
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
application number: M022
Freshness Blueberry Toothpaste100gFRESHNESS BLUEBERRY TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d1dba-87fc-b676-e063-6294a90a14702026-08-06WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114098glycerin 7.5 % Medicated PadPSNdbd7ed86-1b92-4471-827a-89f3afa1b0dc7
1114098glycerin 75 MG/ML Medicated PadSCDdbd7ed86-1b92-4471-827a-89f3afa1b0dc7
1114098glycerin 7.5 % Medicated SwabSYdbd7ed86-1b92-4471-827a-89f3afa1b0dc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68786-160-016878601600110 BOX in 1 CASE (68786-160-01) / 50 PACKET in 1 BOX / 1 mg in 1 PACKET10 box2013-04-110000-00-00NoNoCurrent