openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 7
Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP DEVIATIONS
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP DEVIATIONS
Code information
Lot #: 2E021A, Exp. Date Jan-25
Distribution pattern
Nationwide within the United States
drug · product 3 of 7
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
a) 23,993 plastic jar/folding carton and b) 34,284 plastic jar/folding carton
App-derived interpretation
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP DEVIATIONS
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP DEVIATIONS
Code information
Lot #: a) 0E344A /AA, exp. date N/A; b) 2E243A, Exp. Aug-25
Distribution pattern
Nationwide within the United States
drug · product 5 of 7
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP DEVIATIONS
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP DEVIATIONS
Code information
Lot #: 1E253A, Exp. Date AUG-2024
Distribution pattern
Nationwide within the United States
drug · product 6 of 7
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP DEVIATIONS
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP DEVIATIONS
Code information
Lot #: 2E055A, Exp. Date Feb-2025
Distribution pattern
Nationwide within the United States
drug · product 7 of 7
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
