tetracaine

Generic: tetracaine

Labeler: bellus medical, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tetracaine
Generic Name tetracaine
Labeler bellus medical, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

tetracaine hydrochloride 20 mg/1000mL

Manufacturer
Bellus Medical, LLC

Identifiers & Regulatory

Product NDC 71888-103
Product ID 71888-103_47faba68-aab7-7eb8-e063-6294a90a3931
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2017-06-01

Pharmacologic Class

Classes
ester local anesthetic [epc] esters [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71888103
Hyphenated Format 71888-103

Supplemental Identifiers

UNII
5NF5D4OPCI

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 tetracaine (source: ndc)
Generic Name tetracaine (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1000mL
source: ndc
Packaging
  • 12 PACKET in 1 BOX (71888-103-02) / 4 mL in 1 PACKET (71888-103-01)
source: ndc

Packages (1)

71888-103-02 12 PACKET in 1 BOX (71888-103-02) / 4 mL in 1 PACKET (71888-103-01)

Ingredients (1)

tetracaine hydrochloride (20 mg/1000mL)

Linked Drug Pages (1)

Tetracaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "47faba68-aab7-7eb8-e063-6294a90a3931", "openfda": {"unii": ["5NF5D4OPCI"], "spl_set_id": ["60cabb5f-606b-7a74-e053-2a91aa0ac024"], "manufacturer_name": ["Bellus Medical, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 PACKET in 1 BOX (71888-103-02)  / 4 mL in 1 PACKET (71888-103-01)", "package_ndc": "71888-103-02", "marketing_start_date": "20170601"}], "brand_name": "Tetracaine", "product_id": "71888-103_47faba68-aab7-7eb8-e063-6294a90a3931", "dosage_form": "GEL", "pharm_class": ["Ester Local Anesthetic [EPC]", "Esters [CS]", "Local Anesthesia [PE]"], "product_ndc": "71888-103", "generic_name": "Tetracaine", "labeler_name": "Bellus Medical, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tetracaine", "active_ingredients": [{"name": "TETRACAINE HYDROCHLORIDE", "strength": "20 mg/1000mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170601", "listing_expiration_date": "20271231"}