NDC 52549-4145-8 - Imiquimod

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 52549-4145
Requested NDC: 52549-4145-8
Package NDCs from labels: 52549-4145-8, 52549-4145-6
Manufacturer: Taro Pharmaceutical Industries Ltd.
Effective date: 2011-07-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Imiquimod - Taro Pharmaceutical Industries Ltd.	Taro Pharmaceutical Industries Ltd.	2011-07-12	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52549-4145-6	2020-01-31	C162847	48780-1	9d75b9d0-04e4-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Imiquimod safely and effectively. See full prescribing information for Imiquimod. Imiquimod Cream, 5% For topical use only Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52549-4145-6	Imiquimod	24 in 1 CARTON	CREAM	24		1
52549-4145-8	Imiquimod	0.25 g in 1 PACKET	CREAM	0.25		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52549-4145	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1	Legacy NDC, 2 package rows	20110714_47e471c2-4d26-4393-9f04-297fea8411ac.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Imiquimod	ACTIVE INGREDIENT	P1QW714R7M	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
Imiquimod	ACTIVE MOIETY	P1QW714R7M	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
isostearic acid	INACTIVE INGREDIENT	X33R8U0062	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	IMIQUIMOD CREAM [TARO PHARMACEUTICAL INDUSTRIES LTD.]	1

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 48 · 960 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pharmacys Prescription 4.5 OZ Creamy Petroleum Jelly	WHITE PETROLATUM	American Consumer Products Corp.	5c3eb6b1-d570-0b4c-e063-6394a90af462	2026-09-24	Warnings	Exact identifier unii: 4T6H12BN9U
Lanolin, Petrolatum	LANOLIN, PETROLATUM	CVS Pharmacy, Inc.	606f65a8-08fd-4ab6-9d68-03ddf662bdf0	2026-09-09	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Advanced Healing	PETROLATUM	Walgreen Co.	22bd8e87-965c-466b-bb9b-7d4753e500bc	2026-09-09	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Leader Eye Drops Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Cardinal Health	aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a	2026-09-09	Warnings	Exact identifier unii: PDC6A3C0OX
Drs. Pharmacy baby healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	5b14ffa0-9486-a7fe-e063-6394a90ab3ed	2026-09-09	Warnings	Exact identifier unii: 4T6H12BN9U
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Rite Aid Corporation	407c78ca-6fee-4ed6-b61b-711ec049c86e	2026-09-09	Warnings	Exact identifier unii: 4T6H12BN9U unii: PDC6A3C0OX
Intense Therapy Lip Balm Pineapple Mint	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	0862534c-5f48-4f67-a3b8-0876a667556f	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E	LIP BALM SPF25	Jack Black, LLC	88e8752d-1fbf-4e28-b79d-7c05ecdce842	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	e8730127-2d8d-4b80-ab90-d2f136d9e516	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and Ginger	LIP BALM SUNSCREEN	Jack Black, LLC	d961d22a-2125-41e9-94a3-5b53d12b320f	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Black Tea and Blackberry	LIP BALM SUNSCREEN	Jack Black, LLC	172a70bc-8a09-4258-b9bf-cf3c67ff7613	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Clear Eyes Nighttime	GLYCERIN	Prestige Brands Holdings, Inc.	af75e2f7-81dd-43e0-a390-b52bbfbebf62	2026-09-08	Warnings	Exact identifier unii: PDC6A3C0OX
Intense Therapy Lip Balm Asian Pear	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	acace707-6671-4818-86f2-d9813792157a	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Basil Lemon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	277cb44d-608a-4ffc-a2a5-ac57d33d214c	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Black Cherry	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8f413bd6-258c-4c3c-89d1-369938c85720	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Cucumber Lime	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	5f15bee9-9bf4-4f27-a6b5-4205deb625f6	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Winter Melon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	e7792b4e-a6d2-487e-ba28-27b68e6d7e27	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm Vanilla Bourbon	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	517040d1-e6ed-40ca-a46f-2f75403dbc3c	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Mango and Mandarin	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8c55d1cd-cdd6-468b-8a17-b940c6210116	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intensive Therapy Lip Balm Mango Chili Lime	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	51349d57-b14d-4798-8d68-03fbe3713d1e	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.