D-89-1 Eardrops

Product NDC: 58264-0162
11-digit product format: 582640162
Labeler code: 58264
Product ID: 58264-0162_e0bb1968-986b-555d-e053-2a95a90a5602
Type: HUMAN OTC DRUG
Nonproprietary name: Plantago Major, Umbilicus rupestris, Lobelia Inflata, Matricaria chamomilla, Aloe Vera Leaf, Calendula arvensis whole, and St. Johns Wort
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: DNA Labs, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 1990-01-01
Marketing end: 0000-00-00
Substance: ALOE VERA LEAF; CALENDULA ARVENSIS WHOLE; LOBELIA INFLATA; MATRICARIA CHAMOMILLA; PLANTAGO MAJOR; ST. JOHN'S WORT; UMBILICUS RUPESTRIS
Active strength: 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58264-0162-1	2022-06-06	C162847	48780-1	ba0f9c33-3ada-a910-e053-dadaa90a0b85	9a48e4fb-8d52-423c-9764-68d42a574aed
58264-0162-1	2021-01-29	C162847	48780-1	ba0f9c33-3ada-a910-e053-dadaa90a0b85	9a48e4fb-8d52-423c-9764-68d42a574aed

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZY81Z83H0X	ALOE VERA LEAF	8001-97-6	ALOE VERA LEAF
5PM50140E4	CALENDULA ARVENSIS WHOLE		CALENDULA ARVENSIS WHOLE
9PP1T3TC5U	LOBELIA INFLATA		LOBELIA INFLATA
G0R4UBI2ZZ	MATRICARIA CHAMOMILLA		MATRICARIA CHAMOMILLA
W2469WNO6U	PLANTAGO MAJOR		PLANTAGO MAJOR
UFH8805FKA	ST. JOHN'S WORT	84082-80-4	ST. JOHN'S WORT
X68TXR7V4Y	UMBILICUS RUPESTRIS		UMBILICUS RUPESTRIS

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58264-0162-1	58264016201	29.57 mL in 1 BOTTLE, GLASS (58264-0162-1)	29.57 ml	1990-01-01	0000-00-00	No	No	Current