FDA Orange Book
Generic for Benadryl
Benadryl contains diphenhydramine. 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 Benadryl is diphenhydramine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP. Generics match 2 of the 5 Benadryl products the Orange Book lists.
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Benadryl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 25MG | Discontinued | None | 0 | None |
| capsule, oral | 50MG | Discontinued | None | 0 | None |
| elixir, oral | 12.5MG/5ML | Discontinued | None | 2 | AA |
| injectable, injection | 10MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 50MG/ML | Discontinued | None | 8 | AP |
NDA 005845, 006146, held by MCNEIL CONSUMER HEALTHCARE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diphenhydramine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMACEUTICAL ASSOCIATES INC | 087513 | AA (A-rated, therapeutically equivalent) | February 10, 1982 | 12.5MG/5ML |
| APP PHARMACEUTICALS LLC | 040466 | AP (A-rated, therapeutically equivalent) | May 28, 2002 | 50MG/ML |
| FRESENIUS KABI USA LLC | 091526 | AP (A-rated, therapeutically equivalent) | March 26, 2013 | 50MG/ML |
| MICRO LABS LTD | 205723 | AP (A-rated, therapeutically equivalent) | August 22, 2018 | 50MG/ML |
| GLAND PHARMA LTD | 218448 | AP (A-rated, therapeutically equivalent) | March 20, 2024 | 50MG/ML |
| AVET LIFESCIENCES PRIVATE LTD | 205336 | AP (A-rated, therapeutically equivalent) | June 24, 2025 | 50MG/ML |
| MICRO LABS LTD | 219845 | AP (A-rated, therapeutically equivalent) | August 22, 2025 | 50MG/ML |
| AVET LIFESCIENCES PRIVATE LTD | 205337 | AP (A-rated, therapeutically equivalent) | November 14, 2025 | 50MG/ML |
| ANNORA PHARMA PRIVATE LTD | 219470 | AA (A-rated, therapeutically equivalent) | June 17, 2026 | 12.5MG/5ML |
| WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 080817 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 50MG/ML |
Questions
Is there a generic for Benadryl?
Yes. The generic name for Benadryl is diphenhydramine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP. Generics match 2 of the 5 Benadryl products the Orange Book lists.
What is the generic name for Benadryl?
The active ingredient in Benadryl is diphenhydramine, 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.