Home NDC 53145-007 Breacold Children
Product NDC 53145-007
11-digit product format 531450007
Labeler code 53145
Product ID 53145-007_8273b206-18ec-4768-b844-dd9dfd1fb073
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Dextromethorphan HBR
Dosage form LIQUID
Route ORAL
Labeler Menper Distributors, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-02-21
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10 mg/15mL; mg/15mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53145-007-04 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53145-007-04 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53145-007-04 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53145-007-04 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53145-007-04 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53145-007-04 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53145-007-04 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53145-007-04 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53145-007-04 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53145-007-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53145-007-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53145-007-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53145-007-04 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53145-007-04 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53145-007-04 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-007-04 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-007-04 Breacold Children 1 in 1 CARTON LIQUID 1 3 53145-007-04 Breacold Children 120 mL in 1 BOTTLE LIQUID 120 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 RASPBERRY INACTIVE INGREDIENT 4N14V5R27W BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53145-007 BREACOLD CHILDREN (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 3 Legacy NDC, 2 package rows 20220219_c3d2f57f-7cde-481e-92d8-aaaab0832811.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53145-007-04 53145000704 1 BOTTLE in 1 CARTON (53145-007-04) > 120 mL in 1 BOTTLE 1 bottle 2012-02-21 0000-00-00 No No Current