benzocaine 0.18 MG/MG Oral Gel [Topicale]

RxCUI: 1049213
RxNorm name: benzocaine 0.18 MG/MG Oral Gel [Topicale]
Display name: TOPICALE (Oral Gel)
Full name: benzocaine 0.18 MG/MG Oral Gel [Topicale]
Term type: SBD
Status: Active
Strength: 18%
Dose form: Gel
Route: Oral Gel
Updated: 2026-06-05 07:07:47

RxNorm Status History#

Status: Active
Source: RXNORM
Current: YES
Release start: 012011
Active start: 012011
Multiple ingredient: NO
Branded: YES

Ingredients And Strength#

Ingredient, Strength, Base table
Ingredient	Strength	Base	Basis of strength
benzocaine	0.18 MG / 1 MG	benzocaine	benzocaine

Dose Form Concepts#

Dose form, RxCUI table
Dose form	RxCUI
Oral Gel	346169

Derived Ingredient Concepts#

Ingredient, RxCUI table
Ingredient	RxCUI
benzocaine	1399

Source Vocabulary Codes#

Code type, Values, Count table
Code type	Values	Count	Category
PRESCRIBABLE	Y	1	ATTRIBUTES
RXNAV_STR	Topicale 18 % Oral Gel	1	NAMES
RxNorm Name	benzocaine 0.18 MG/MG Oral Gel [Topicale]	1	NAMES
RxNorm Synonym	2 linked values Topicale 0.18 MG/MG Oral Gel Topicale 18 % Oral Gel	2	NAMES
TTY	SBD	1	ATTRIBUTES
SPL_SET_ID	2 linked values 826eaef8-4457-3dc2-e053-2991aa0a528b 8281700c-10f9-841c-e053-2991aa0a918f	2	CODES
RxCUI	1049213	1	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
10733-166-35	10733-166	Topicale Benzocaine	Medical Products Laboratories, Inc.	M022
10733-167-43	10733-167	Topicale Benzocaine	Medical Products Laboratories, Inc.	M022
10733-169-43	10733-169	Topicale Benzocaine	Medical Products Laboratories, Inc.	M022
10733-170-43	10733-170	Topicale Benzocaine	Medical Products Laboratories, Inc.	M022
10733-171-43	10733-171	Topicale Benzocaine	Medical Products Laboratories, Inc.	M022

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
M022	10733-166	Topicale Benzocaine	OTC MONOGRAPH DRUG	Medical Products Laboratories, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.

NDC11, Source, Active table
NDC11	Source	Active
10733016635	rxnav_ndcs	yes
10733016743	rxnav_ndcs	yes
10733016943	rxnav_ndcs	yes
10733017043	rxnav_ndcs	yes
10733017143	rxnav_ndcs	yes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	826eaef8-4457-3dc2-e053-2991aa0a528b	2024-12-11	Warnings	Exact identifier ndc (package): 10733-166-35 ndc (product): 10733-166 ndc11 (package): 10733016635 rxcui: 1049213
Topicale	BENZOCAINE	Medical Products Laboratories, Inc.	8281700c-10f9-841c-e053-2991aa0a918f	2024-12-11	Warnings	Exact identifier ndc (package): 10733-169-43 ndc (package): 10733-170-43 ndc (package): 10733-171-43 ndc (package): 10733-167-43 ndc (product): 10733-171 ndc (product): 10733-170 ndc (product): 10733-167 ndc (product): 10733-169 ndc11 (package): 10733017043 ndc11 (package): 10733016743 ndc11 (package): 10733016943 ndc11 (package): 10733017143 rxcui: 1049213

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
826eaef8-4457-3dc2-e053-2991aa0a528b	Topicale 18 % Oral Gel [PSN] · benzocaine 0.18 MG/MG Oral Gel [Topicale] [SBD] · Topicale 0.18 MG/MG Oral Gel [SY] · Topicale 18 % Oral Gel [SY]	4	4	Topicale Gel Jar	20241211
8281700c-10f9-841c-e053-2991aa0a918f	Topicale 18 % Oral Gel [PSN] · benzocaine 0.18 MG/MG Oral Gel [Topicale] [SBD] · Topicale 0.18 MG/MG Oral Gel [SY] · Topicale 18 % Oral Gel [SY]	4	3	Topicale Gel Pump	20241211

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
826eaef8-4457-3dc2-e053-2991aa0a528b	Topicale Gel Jar	Medical Products Laboratories, Inc.	20241211
8281700c-10f9-841c-e053-2991aa0a918f	Topicale Gel Pump	Medical Products Laboratories, Inc.	20241211

Drug Classes#

Source, Class ID, Class table
Source	Class ID	Class	Type	Relationship	Drug concept
ATC	D04AB	Anesthetics for topical use	ATC1-4		benzocaine
ATC	R02AD	Anesthetics, local	ATC1-4		benzocaine
ATC	N01BA	Esters of aminobenzoic acid	ATC1-4		benzocaine
ATC	C05AD	Local anesthetics	ATC1-4		benzocaine
FDASPL	N0000185508	Standardized Chemical Allergen	EPC	has_epc	benzocaine
FDASPL	N0000184306	Cell-mediated Immunity	PE	has_pe	benzocaine
FDASPL	N0000175629	Increased Histamine Release	PE	has_pe	benzocaine
MEDRT	D001566	Benzocaine	CHEM	has_ingredient	benzocaine
MEDRT	D001424	Bacterial Infections	DISEASE	ci_with	benzocaine
MEDRT	D002056	Burns	DISEASE	may_treat	benzocaine
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	benzocaine
MEDRT	D004433	Earache	DISEASE	may_treat	benzocaine
MEDRT	D005401	Fissure in Ano	DISEASE	may_treat	benzocaine
MEDRT	D006484	Hemorrhoids	DISEASE	may_treat	benzocaine
MEDRT	D006561	Herpes Simplex	DISEASE	may_treat	benzocaine
MEDRT	D019226	Oral Ulcer	DISEASE	may_treat	benzocaine
MEDRT	D010032	Otitis Externa	DISEASE	may_treat	benzocaine
MEDRT	D010033	Otitis Media	DISEASE	may_treat	benzocaine
MEDRT	D010146	Pain	DISEASE	may_prevent	benzocaine
MEDRT	D011537	Pruritus	DISEASE	may_treat	benzocaine
MEDRT	D014098	Toothache	DISEASE	may_treat	benzocaine
MEDRT	N0000000180	Sodium Channel Interactions	MOA	has_moa	benzocaine
MEDRT	N0000008889	Decreased Sensory-Somatic Nervous System Organized Electrical Activity	PE	has_pe	benzocaine

Group, Type, Concept table
Group	Type	Concept	Source
BN	BN	Topicale	rxnav_allrelated
DF	DF	Oral Gel	rxnav_allrelated
DFG	DFG	Oral Gel Product	rxnav_allrelated
DFG	DFG	Oral Product	rxnav_allrelated
IN	IN	benzocaine	rxnav_allrelated
SBD	SBD	benzocaine 0.18 MG/MG Oral Gel [Topicale]	rxnav_allrelated
SBDC	SBDC	benzocaine 0.18 MG/MG [Topicale]	rxnav_allrelated
SBDF	SBDF	benzocaine Oral Gel [Topicale]	rxnav_allrelated
SBDG	SBDG	Topicale Oral Gel Product	rxnav_allrelated
SBDG	SBDG	Topicale Oral Product	rxnav_allrelated
SCD	SCD	benzocaine 0.18 MG/MG Oral Gel	rxnav_allrelated
SCDC	SCDC	benzocaine 0.18 MG/MG	rxnav_allrelated
SCDF	SCDF	benzocaine Oral Gel	rxnav_allrelated
SCDG	SCDG	benzocaine Oral Gel Product	rxnav_allrelated
SCDG	SCDG	benzocaine Oral Product	rxnav_allrelated

Properties#

Category, Property, Value table
Category	Property	Value
ATTRIBUTES	AVAILABLE_STRENGTH	0.18 MG/MG
ATTRIBUTES	GENERAL_CARDINALITY	SINGLE
ATTRIBUTES	HUMAN_DRUG	US
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
NAMES	Prescribable Synonym	Topicale 18 % Oral Gel
SOURCES	Source	Gold Standard Alchemy
SOURCES	Source	Metathesaurus FDA Structured Product Labels