Home NDC 16477-306 Respaire-30
Product NDC 16477-306
11-digit product format 164770306
Labeler code 16477
Product ID 16477-306_9223f739-d855-446c-e053-2a95a90a22c6
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN
Dosage form CAPSULE
Route ORAL
Labeler Laser Pharmaceuticals, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2008-09-02
Marketing end 2019-11-30
Substance GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 150 mg/1; mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 16477-306-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 16477-306-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 16477-306-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 16477-306-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 16477-306-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 16477-306-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 16477-306-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 16477-306-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 16477-306-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 16477-306-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 16477-306-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 16477-306-01 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 CHLORIDE ION ACTIVE MOIETY Q32ZN48698 RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RESPAIRE-30 (GUAIFENESIN) CAPSULE [LASER PHARMACEUTICALS, LLC] 2