OTC benzocaine teething gels withdrawn in USA

In late May, the FDA issued a warning to consumers that OTC teething products containing benzocaine pose a serious health risk to infants and children. The agency said that all oral products containing the pain reliever for temporary relief of sore gums owing to teething should no longer be marketed and is asking companies to stop selling them for this use.

Additionally companies are being requested to add new warnings to all other benzocaine oral health products to describe serious health risk of methemoglobinaemia, a blood disorder that impairs the body’s ability to use oxygen that has been linked to benzocaine use.

Affected brands include Anbesol (Pfizer), Baby Orajel and Orajel (Church & Dwight), Cepacol (Reckitt Benckiser), Chloraseptic (Prestige Brands), Hurricaine (Beutlich Pharmaceuticals), Orabase (Colgate) and Topex (Sultan Healthcare), as well as store brands and generics.


Figures from Nicholas Hall’s global OTC database, DB6, indicate that the US mouth & dental analgesics category was worth US$126mn in 2017. Before this latest warning, sales were already in decline (-4%) owing to an FDA warning on homeopathic teething products in September 2016. Standard Homeopathic has now re-entered the market with the launch of Hyland’s Baby Oral Pain, 4Kids Oral Pain Relief and 4Kids Oral Pain Relief Nighttime Tablets without belladona or benzocaine. 

Orajel (Church & Dwight) is the leading brand with a 56% share of sales and, according to DB6, some 90% of all mouth & dental analgesics in the US are currently formulated with benzocaine, including the leading brands Orajel and Anbesol. On its brand website, C&D stated that Orajel Medicated Teething Gel, Orajel Medicated Nighttime Teething Gel, Orajel Medicated Daytime & Nighttime Teething Twin Pack and Orajel Medicated Teething Swabs had all been discontinued with immediate effect.

Comment from OTC.NewDirections Consulting Editor, Nina Stimson: This move was probably inevitable, given safety concerns and earlier action against other children’s meds such as cough remedies, but it’s likely to cause a few sleepless nights for parents, teething babies and marketers alike until they figure out the way forward … Official advice to parents now suggests that they should gently massage infants’ sore gums but avoid medication. We think quite a few may turn to a children’s or infants’ systemic analgesic …

To stay up-to-date with the latest regulatory changes, subscribe to OTC.NewDirections, and also meet like-minded professionals at our 1st OTC.NewDirections Executive Conference in London on 12th September 2018Where Innovation meets Regulation. Nicholas Hall and Nina Stimson will be joined by representatives from players including Angelini, Kanabo Research and Medical Brands to review, discuss and debate the major issues impacting innovation, regulation and competition. Sessions cover diverse topics such as New Product Opportunities, Regulatory Affairs (including Switch), Medical Devices and Digital Health, plus Herbals & Naturals and the fast-developing Medical Cannabis market. Book now and benefit from our early bird discounts by contacting lianne.hill@NicholasHall.com

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