FDA Orange Book
Generic for Children's Advil
Children's Advil contains ibuprofen. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Children's Advil is ibuprofen. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Children's Advil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 100MG/5ML | Discontinued | None | 5 | AB |
NDA 019833, held by HALEON US HOLDINGS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ibuprofen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS MID ATLANTIC LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 074978 | AB (A-rated, therapeutically equivalent) | March 25, 1998 | 100MG/5ML |
| PADAGIS US LLC | 076925 | AB (A-rated, therapeutically equivalent) | September 23, 2004 | 100MG/5ML |
| SUN PHARMA CANADA INC | 209204 | AB (A-rated, therapeutically equivalent) | June 23, 2017 | 100MG/5ML |
| AUROBINDO PHARMA LTD | 209178 | AB (A-rated, therapeutically equivalent) | February 16, 2018 | 100MG/5ML |
| STRIDES PHARMA GLOBAL PTE LTD | 215311 | AB (A-rated, therapeutically equivalent) | May 27, 2022 | 100MG/5ML |
Questions
Is there a generic for Children's Advil?
Yes. The generic name for Children's Advil is ibuprofen. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Children's Advil?
The active ingredient in Children's Advil is ibuprofen, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.