zensa numbing gel

Generic: lidocaine 5%, phenylephrine hydrochloride 0.25%

Labeler: alera skin care products inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name zensa numbing gel
Generic Name lidocaine 5%, phenylephrine hydrochloride 0.25%
Labeler alera skin care products inc.
Dosage Form GEL
Routes
RECTAL
Active Ingredients

lidocaine 5 g/100g, phenylephrine hydrochloride .25 g/100g

Manufacturer
Alera Skin Care Products Inc.

Identifiers & Regulatory

Product NDC 69805-400
Product ID 69805-400_065a6eec-3897-0da8-e063-6394a90a849d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2023-09-25

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc] antiarrhythmic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69805400
Hyphenated Format 69805-400

Supplemental Identifiers

RxCUI
2621576
UPC
0628235620154
UNII
98PI200987 04JA59TNSJ
NUI
N0000175682 M0000897 N0000175426 N0000175976

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zensa numbing gel (source: ndc)
Generic Name lidocaine 5%, phenylephrine hydrochloride 0.25% (source: ndc)
Application Number M015 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 5 g/100g
  • .25 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69805-400-01) / 30 g in 1 TUBE
source: ndc

Packages (1)

69805-400-01 1 TUBE in 1 CARTON (69805-400-01) / 30 g in 1 TUBE

Ingredients (2)

lidocaine (5 g/100g) phenylephrine hydrochloride (.25 g/100g)

Linked Drug Pages (1)

Zensa Numbing Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "065a6eec-3897-0da8-e063-6394a90a849d", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0628235620154"], "unii": ["98PI200987", "04JA59TNSJ"], "rxcui": ["2621576"], "spl_set_id": ["065a6eec-3896-0da8-e063-6394a90a849d"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Alera Skin Care Products Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69805-400-01)  / 30 g in 1 TUBE", "package_ndc": "69805-400-01", "marketing_start_date": "20230925"}], "brand_name": "Zensa Numbing Gel", "product_id": "69805-400_065a6eec-3897-0da8-e063-6394a90a849d", "dosage_form": "GEL", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69805-400", "generic_name": "Lidocaine 5%, Phenylephrine Hydrochloride 0.25%", "labeler_name": "Alera Skin Care Products Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Zensa Numbing Gel", "active_ingredients": [{"name": "LIDOCAINE", "strength": "5 g/100g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".25 g/100g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230925", "listing_expiration_date": "20261231"}