Claim adjustment reason code
Denial code CO-114 meaning
CARC 114, usually seen as CO-114: The procedure or product is not approved by the FDA.
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- Reason code
- CARC 114
- Short name
- Not approved by the FDA
- Plain meaning
- The procedure or product is not approved by the FDA.
- Group codes
- CO-114: Contractual obligation. The provider absorbs the amount under its contract or the payer's rules. Do not bill the patient for it.
Plain-English summary written by Rivvi. X12 owns the CARC list and its exact wording, which is not reproduced here. Read it on the X12 CARC list (list dated November 1, 2025, checked October 23, 2026). This page does not decide how a claim is paid.
Common causes
- The drug or device is not FDA approved, or not for this use under the payer's policy.
What to check before resubmitting
- Check the product's FDA status and the payer's policy.
Related reason codes
Related pages
Questions
What does denial code CO-114 mean?
The procedure or product is not approved by the FDA. This is Rivvi's plain-English summary of CARC 114. X12's exact wording is on x12.org.
How do I fix CO-114?
Check the product's FDA status and the payer's policy.
Can I bill the patient for CO-114?
With group code CO, no. CO means the provider absorbs the amount under its contract or the payer's rules.
Which group codes come with CARC 114?
Most often CO (contractual obligation). The group code, not the reason code, says who owes the amount.
What is the difference between a CARC and a RARC?
A claim adjustment reason code (CARC) says why a claim line was paid differently than billed. A remittance advice remark code (RARC) adds detail, such as which field is missing.