Search by Drug Name or NDC

NDC 52183-0259-14 Ludens Honey Licorice Throat Drops 1 mg/1 Details

Ludens Honey Licorice Throat Drops 1 mg/1

Ludens Honey Licorice Throat Drops is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Prestige Brands Holdings, Inc.. The primary component is MENTHOL.

Product Information

NDC	52183-0259
Product ID	52183-259_bdd552bf-5b1d-411b-8155-1efa4d420fbd
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ludens Honey Licorice Throat Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	1
Active Ingredient Units	mg/1
Substance Name	MENTHOL
Labeler Name	Prestige Brands Holdings, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52183-0259-14 (52183025914)

Pricing Information	N/A
NDC Package Code	52183-259-14
Billing NDC	52183025914
Package	14 LOZENGE in 1 CARTON (52183-259-14)
Marketing Start Date	2009-10-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac Details

SPL UNCLASSIFIED SECTION

Luden’s Original Menthol Throat Drops

Drug Facts

Active ingredient (in each drop)

Menthol 2.5 mg

Purpose

Oral anesthetic

Uses

temporarily relieves: occasional minor irritation, pain, sore mouth, and sore throat

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.

Stop use and ask a doctor if:

sore mouth does not improve in 7 days
irritation, pain or redness lasts or worsens.

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children

Directions

adults and children 3 years of age and older: allow drop to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by doctor.
children under 3 years of age: ask a doctor

Other information

store at 20-25ºC (68-77ºF) in a dry place
Do not use if clear outer wrap is opened or missing.

Inactive ingredients

Caramel Color, Corn Syrup, Flavors, Sodium Acetate, Soybean Oil used as a processing aid, Sucrose, Water

Questions or comments?

Call 1-866-583-3677

Luden’s Honey Licorice Throat Drops

Drug Facts

Active ingredient (in each drop)

Menthol 1.0 mg

Purpose

Oral anesthetic

Uses

temporarily relieves: occasional minor irritation, pain, sore mouth, and sore throat

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness lasts or worsens

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children

Directions

adults and children 3 years of age and older: allow 2 drops to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor.
children under 3 years of age: ask a doctor

Other information

store at 20-25ºC (68-77ºF) in a dry place
do not use if clear outer wrap is opened or missing.

Inactive ingredients

Caramel Color, Corn Syrup, Flavors, Glycerin, Honey, Sodium Acetate, Soybean Oil used as a processing aid, Sucrose, Water

Questions or comments?

call 1-866-583-3677

Luden’s Honey Licorice Throat Drops

Drug Facts

Active ingredient (in each drop)

Menthol 1.6 mg

Purpose

Oral anesthetic

Uses

for temporary relief of occasional minor irritation, pain, sore mouth, and sore throat

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

Directions

Adults and children 3 years of age and older:
allow 1 drop at a time to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor.
Children under 3 years of age: ask a doctor

Other information

store at 20-25ºC (68-77ºF) in a dry place

Inactive ingredients

caramel color, corn syrup, flavors, glycerin, honey, sodium acetate, soybean oil, sucrose.

Questions?

1-866-583-3677 Ludens.com

Luden’s Honey Lemon Throat Drops

Drug Facts

Active ingredient (in each drop)

Menthol 1.0 mg

Purpose

Oral anesthetic

Uses

temporarily relieves: occasional minor irritation, pain, sore mouth, and sore throat

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness lasts or worsens

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children

Directions

adults and children 3 years of age and older: allow 2 drops to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor.
children under 3 years of age: ask a doctor

Other information

store at 20-25ºC (68-77ºF) in a dry place
do not use if clear outer wrap is opened or missing.
contains FD&C yellow no. 5 (tartrazine) as a color additive

Inactive ingredients

ascorbic acid, citric acid, corn syrup, FD&C yellow 5, flavors, honey, sodium acetate, sodium chloride, soybean oil, sucrose

Questions?

1-866-583-3677 Ludens.com

Luden’s Honey Lemon Throat Drops

Drug Facts

Active ingredient (in each drop)

Menthol 1.6 mg

Purpose

Oral anesthetic

Uses

for temporary relief of occasional minor irritation, pain, sore mouth, and sore throat

Warnings

Stop use and ask a doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

Directions

Adults and children 3 years of age and older: 2 drops.
allow 1 drop at a time to dissolve slowly in mouth. Repeat as necessary every 2 hours, or as directed by a doctor.
Children under 3 years of age: ask a doctor

Other information

store at 20-25ºC (68-77ºF) in a dry place
contains FD&C yellow no. 5 (tartrazine) as a color additive

Inactive ingredients

caramel color, corn syrup, flavors, glycerin, honey, sodium acetate, soybean oil, sucrose.

Questions?

1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL

LUDEN’S

ORIGINAL MENTHOL

Menthol lozenge

Oral Anesthetic

14 Drops

Principal Display Panel

LUDEN’S

HONEY LICORICE

Menthol lozenge/Oral Anesthetic

20 Drops

Principal Display Panel

LUDEN’S

HONEY LICORICE

Menthol lozenge

Oral Anesthetic

30 Drops

Principal Display Panel

LUDEN’S

HONEY LEMON

Menthol lozenge

Oral Anesthetic

14 Drops

Principal Display Panel

LUDEN’S

HONEY LEMON

Menthol lozenge

Oral Anesthetic

30 Drops

INGREDIENTS AND APPEARANCE

LUDENS ORIGINAL MENTHOL THROAT DROPS

menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-279
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 mg

Ingredient Name	Strength
Inactive Ingredients
CORN SYRUP (UNII: 9G5L16BK6N)
SODIUM ACETATE (UNII: 4550K0SC9B)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	BROWN	Score	no score
Shape	CAPSULE	Size	22mm
Flavor	MENTHOL	Imprint Code	LUDENS
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-279-14	14 in 1 CARTON; Type 0: Not a Combination Product	10/29/2009	08/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	10/29/2009	08/31/2017

LUDENS HONEY LICORICE THROAT DROPS

menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-259
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.0 mg

Ingredient Name	Strength
Inactive Ingredients
CORN SYRUP (UNII: 9G5L16BK6N)
GLYCERIN (UNII: PDC6A3C0OX)
HONEY (UNII: Y9H1V576FH)
SODIUM ACETATE (UNII: 4550K0SC9B)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BLACK	Score	no score
Shape	CAPSULE	Size	21mm
Flavor	LICORICE	Imprint Code	LUDENS
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52183-259-14	14 in 1 CARTON; Type 0: Not a Combination Product	10/29/2009
2	NDC:52183-259-20	20 in 1 BOX; Type 0: Not a Combination Product	10/29/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	10/29/2009

LUDENS HONEY LEMON THROAT DROPS

menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-269
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.0 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HONEY (UNII: Y9H1V576FH)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	23mm
Flavor	LEMON (Honey Lemon)	Imprint Code	LUDENS
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-269-14	14 in 1 CARTON; Type 0: Not a Combination Product	10/29/2009	08/31/2021
2	NDC:52183-269-30	30 in 1 BAG; Type 0: Not a Combination Product	10/29/2009	08/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	10/29/2009	08/31/2021

LUDENS HONEY LICORICE THROAT DROPS

menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-255
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.6 mg

Ingredient Name	Strength
Inactive Ingredients
CORN SYRUP (UNII: 9G5L16BK6N)
SODIUM ACETATE (UNII: 4550K0SC9B)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)
HONEY (UNII: Y9H1V576FH)

Product Characteristics
Color	BLACK	Score	no score
Shape	CAPSULE	Size	22mm
Flavor	LICORICE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-255-30	30 in 1 BAG; Type 0: Not a Combination Product	10/29/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	10/29/2009

LUDENS HONEY LEMON THROAT DROPS

menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-266
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.6 mg

Ingredient Name	Strength
Inactive Ingredients
CORN SYRUP (UNII: 9G5L16BK6N)
SODIUM ACETATE (UNII: 4550K0SC9B)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
HONEY (UNII: Y9H1V576FH)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	22mm
Flavor	LEMON	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-266-30	30 in 1 BAG; Type 0: Not a Combination Product	10/29/2009	08/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	10/29/2009	08/31/2021

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 6/2020

Document Id: bdd552bf-5b1d-411b-8155-1efa4d420fbd

Set id: 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac

Version: 7

Effective Time: 20200630

Search by Drug Name or NDC

NDC 52183-0259-14 Ludens Honey Licorice Throat Drops 1 mg/1 Details

Ludens Honey Licorice Throat Drops 1 mg/1

Product Information

Package

Package Images

NDC 52183-0259-14 (52183025914)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if:

If pregnant or breast-feeding,

Keep out of reach of children

Directions

Other information

Inactive ingredients

Questions or comments?

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children

Directions

Other information

Inactive ingredients

Questions or comments?

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children

Directions

Other information

Inactive ingredients

Questions?

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children

Directions

Other information

Inactive ingredients

Questions?

Active ingredient (in each drop)

Purpose

Uses

Warnings

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children

Directions

Other information

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL

Principal Display Panel

Principal Display Panel

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE