Gaayou Numbing

Product NDC: 85248-150
11-digit product format: 852480150
Labeler code: 85248
Product ID: 85248-150_4c290118-7881-2a98-e063-6294a90a4c03
Type: HUMAN OTC DRUG
Nonproprietary name: Dibucaine hydrochloride 0.5% Numbing
Dosage form: CREAM
Route: TOPICAL
Labeler: Jiangxi Yudexi Pharmaceutical Co., LTD
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-03-04
Substance: DIBUCAINE HYDROCHLORIDE
Active strength: .5 g/100g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 85248-150_4c290118-7881-2a98-e063-6294a90a4c03
SPL ID: 4c290118-7881-2a98-e063-6294a90a4c03
Product type: HUMAN OTC DRUG
Finished product: Yes
Brand name base: Gaayou Numbing
Generic name: Dibucaine hydrochloride 0.5% Numbing
Dosage form: CREAM
Route: TOPICAL
Marketing start: 2026-03-04
Marketing category: OTC MONOGRAPH DRUG
Application number: M017
Pharmacologic classes: Allergens [CS]; Cell-mediated Immunity [PE]; Increased Histamine Release [PE]; Standardized Chemical Allergen [EPC]
Listing expiration: 2027-12-31

Ingredient	Strength
DIBUCAINE HYDROCHLORIDE	.5 g/100g

Field	Values
Unii	Z97702A5DG
Rxcui	2738108
Spl Set Id	4c290118-7880-2a98-e063-6294a90a4c03
Manufacturer Name	Jiangxi Yudexi Pharmaceutical Co., LTD

Package NDC	Description	Marketing start	Sample
85248-150-01	50 g in 1 BOTTLE (85248-150-01)	2026-03-04	No

UNII	Preferred term	Registry number	Matched term
Z97702A5DG	DIBUCAINE HYDROCHLORIDE	61-12-1	DIBUCAINE HYDROCHLORIDE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85248-150-01	85248015001	50 g in 1 BOTTLE (85248-150-01)	50 g	2026-03-04	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
85248-150	Jiangxi Yudexi Pharmaceutical Co., LTD	2026-03-03	HUMAN OTC DRUG LABEL	1