BENZEDREX
- Product NDC
- 0225-0610
- 11-digit product format
- 002250610
- Labeler code
- 0225
- Product ID
- 0225-0610_ec979cf7-fbd0-b974-e053-2995a90aec84
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- PROPYLHEXEDRINE
- Dosage form
- INHALANT
- Route
- NASAL
- Labeler
- BF ASCHER AND CO INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2014-09-19
- Marketing end
- 0000-00-00
- Substance
- PROPYLHEXEDRINE
- Active strength
- 250 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0225-0610 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 0225-0610 | 0225-0610-23 | D | Discontinued by firm | 2026-10-15 |
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.
| 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 | 0225-0610-23 | 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 | 0225-0610-23 | 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 | 0225-0610-23 | 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 | 0225-0610-23 | 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 | 0225-0610-23 | 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 | 0225-0610-23 | cdf11ea48f46… | ba0047e9e063… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0225-0610-23 | EA - Each | 0225-0610 | a5e71a11-6b7c-43aa-b69e-cb0fed8ae8db | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PROPYLHEXEDRINE | ACTIVE INGREDIENT | LQU92IU8LL | BENZEDREX 09-19-2014 (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC] | 2 | |
| PROPYLHEXEDRINE | ACTIVE MOIETY | LQU92IU8LL | BENZEDREX 09-19-2014 (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC] | 2 | |
| LAVENDER OIL | INACTIVE INGREDIENT | ZBP1YXW0H8 | BENZEDREX 09-19-2014 (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC] | 2 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | BENZEDREX 09-19-2014 (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC] | 2 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 14c56f3d-67fd-45ef-a16b-f27604722883 | 2026-05-12 | Warnings | M012 |
| ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare, LLC. | 51a4195b-8776-964c-e063-6294a90aa075 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | fe7eeb71-e219-4c84-ac06-98c3a40b14dc | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 6f8241d7-0f30-40b3-926b-861c57079f1d | 2026-05-12 | Warnings | M012 |
| Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51a45db8-2bee-6fd0-e063-6394a90ab587 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 19da539e-7b57-41d7-aad5-fc89a6705e20 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 182222b5-a852-4dbe-b05f-a41d89806021 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8a790eeb-7d7d-4a94-9103-6ed09c04d596 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | dbdafbb4-f3c9-4042-b867-db4d06dc3d61 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d03ef2fd-1a08-42c0-b69d-fd4e4285ccd3 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 29571047-4c4b-44ca-8726-57c28308e8cf | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 75c6b92f-219f-4740-bb72-c02a927a21ff | 2026-05-12 | Warnings | M012 |
| Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | c746953f-4b7d-4e2a-9b85-96bd6901f517 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | cea08797-1d53-4434-be1a-144f2ded5f9d | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2ef9d5de-e99e-4398-bf97-c7bef94498fa | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a401eb92-60b6-427d-a677-29371a3150be | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7c18e95-8d7b-4550-9a20-fc704a114adb | 2026-05-12 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0225-0610-23 | 00225061023 | 1 INHALANT in 1 INHALER (0225-0610-23) | 1 inhalant | 2014-09-19 | 0000-00-00 | No | No | Current |