NDC Number

Most new manufacturers of OTC drugs like sunscreen, hand sanitizer etc... are confused of how to assign NDC Number for their drug,

FDA will assign only the first part of (first 4 or 5 digits) 10 digit NDC number, the labeler need to assign the remaining 5 or 6 digits. The manufacturer does not need to send product sample or label for registration.

For more information about NDC number / Labeler code assignment or to request an NDC labeler code for your establishment please contact us at info@fdahelp.us

Examples of labeler code assigned by different manufacturers for different products are given below.

NDC / NHRIC Number

Labeler Name


NDC Number 59779-378-12 CVS Pharmacy Sunscreen
NDC Number 49738-694-11 Kmart Corporation Sunscreen
NDC Number 61649-001-75 Bio Spectra Sunscreen
NDC Number 10096-0314-1 Avon Products, Inc Sunscreen
NDC Number 0363-3216-01 Walgreens Sunscreen
NDC Number 11673-370-16 Target Corp Hand Sanitizer
NDC Number 72036-439-16 Harris Teeter Hand Sanitizer
NDC Number 49348-477-37 McKesson Hand Sanitizer
NDC Number 42961-005-02 Cintas Corp Hand Sanitizer
NDC Number 55910-988-36 Dolgencorp Inc Hand Sanitizer
NDC Number 41167-0980-6 Chattem, Inc Mouthwash
NDC Number 64893-500-00 Dr. Fresh, Inc Mouthwash
NDC Number 67933-0008-1 Willard Manufacturing Inc. Mouthwash
NDC Number 11673-090-01 Target Corporation Mouthwash
NDC Number 10210-0008-0 Carma Laboratories, Inc. Analgesic
NDC Number 59779-997-28 CVS Pharmacy, Inc Analgesic
NDC Number 52920-134-49 Singhfam Corporation Analgesic
NDC Number 49738-702-64 Kmart Corporation Analgesic
NDC Number 11673-667-02 Target Corporation Analgesic
FDA Registration and U.S. Agent service USD 649 (Annually)
Drug Listing USD 399 / Drug
Label Review USD 649 / Drug
DMF Submission and U.S. Agent service USD 649/ (Annually)

Fees for other services


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Phone : +1 (630) 270-2921
Fax : +1 (815) 986-2632
E-mail : info@fdahelp.us