Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide): Guidance for Industry

Scope & Applicability

• 21CFR207.21§ 207.21 When must initial registration information be provided?

  (a) Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug or an animal feed bearing or containing a new animal drug at such establishment.Read full regulation →

• 21CFR201.66§ 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.

  (a) Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products. Where an OTC drug product is the subject of an applicable monograph or regulation that contains content and format requirements that conflict with this section, the content and format reRead full regulation →

• 21CFR341.40§ 341.40 Permitted combinations of active ingredients.

  The following combinations are permitted provided each active ingredient is present within the dosage limits established in parts 341 , 343 , and 356 of this chapter and the product is labeled in accordance with §§ 341.70 or 341.85 :Read full regulation →

• 21CFR341.16§ 341.16 Bronchodilator active ingredients.

  The active ingredients of the product consist of any of the following when used within the dosage limits established for each ingredient:Read full regulation →

• 21CFR341.76§ 341.76 Labeling of bronchodilator drug products.

  (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “bronchodilator.”Read full regulation →

• Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

  Guangzhou Zhongkebaishi Health Industry Co., Ltd.

  2022-04-26

• CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

  Notarika, S.A. de C.V.

  2021-10-12

• Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

  Guangzhou Minghui Cosmetics Co., Ltd.

  2021-07-13

• Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

  Distribuidora Lagunera del Norte S.A. de C.V.

  2021-03-30

• Unapproved New Drugs/Misbranded

  Essential Pharmaceutical Corp

  2020-10-06

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