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 | 2026-10-21 | ||
| excluded package | package | 0225-0610 | 0225-0610-23 | D | Discontinued by firm | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| Rompe Pecho CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Dextrum Laboratories, Inc | 401a97af-36ae-4e54-e063-6294a90ab3ee | 2025-10-01 | Warnings | M012 |
| NyQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | 724d0889-5ba5-3125-e053-2a91aa0a92c1 | 2025-10-01 | Warnings | M012 |
| DayQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 724f2833-34bd-6a9e-e053-2991aa0a073d | 2025-10-01 | Warnings | M012 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | InvaTech Pharma Solutions LLC | b8d360fa-0d80-f6a8-e053-2a95a90a8bd4 | 2025-10-01 | M012 | |
| LEADER TUSSIN CF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | f4ffe87b-0a62-44ac-b84a-08cf77cda7f5 | 2025-10-01 | Warnings | M012 |
| Nasal Spray, 1oz, 24/7 Life by 7-Eleven | OXYMETAZOLINE HCL NASAL SOLUTION 0.05% | Lil' Drug Store Products, Inc. | 3e781417-9ffc-f2c9-e063-6294a90a7205 | 2025-09-30 | Warnings | M012 |
| Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf | 2025-09-30 | Warnings | M012 |
| Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dextrum Laboratories, Inc | 3ff240ba-90b2-4c17-e063-6394a90ac56f | 2025-09-29 | Warnings | M012 |
| Dometuss | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dextrum Laboratories, Inc | 3fcace53-a81f-e774-e063-6294a90a32fa | 2025-09-27 | Warnings | M012 |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | f6a3680a-3ac6-4fd4-be52-ce29064c4aa1 | 2025-09-26 | Warnings | M012 |
| No Drip Severe Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | 9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae5 | 2025-09-26 | Warnings | M012 |
| Giltuss Allergy Plus | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3fa0b3be-2124-ed1d-e063-6294a90aaf48 | 2025-09-25 | Warnings | M012 |
| MGC Health Cough Drops Honey Herb | MENTHOL | Medical Group Care LLC | 3fa17255-514f-db47-e063-6294a90ae454 | 2025-09-25 | Warnings | M012 |
| MGC Health Cough Drops Honey Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3fa17272-fd7f-9ab4-e063-6394a90a585f | 2025-09-25 | Warnings | M012 |
| MGC Health Throat Soothing Drops Creamy Strawberry | PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3fa2e438-2ff3-a2df-e063-6394a90ac7b5 | 2025-09-25 | Warnings | M012 |
| QUALITY CHOICE ADULT TUSSIN EXPECTORANT | GUAIFENESIN | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 63dad603-fe2f-42a6-a626-5c8048a42c10 | 2025-09-25 | Warnings | M012 |
| Giltuss Childrens Allergy Plus | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3fa5220f-38bb-9ef6-e063-6294a90aeff8 | 2025-09-25 | Warnings | M012 |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Health Pharma USA LLC | a03befb4-d86d-43e4-8097-eda5c8bb25be | 2025-09-24 | Warnings | M012 |
| Childrens Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f8d7d47-f14c-888c-e063-6394a90a5cdd | 2025-09-24 | Warnings | M012 |
| Childrens Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dextrum Laboratories, Inc | 3f909bc2-eb84-a19d-e063-6294a90ae04e | 2025-09-24 | 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 |