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 | 2026-10-23 | ||
| excluded package | package | 0225-0610 | 0225-0610-23 | D | Discontinued by firm | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e3dd12f1-dd63-27ae-e053-2995a90aaaeb | 2024-10-17 | Warnings | M012 |
| COLD and FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e44ac549-3e9b-4271-a2b2-ecb124f79832 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | f171a389-8b22-429c-86bc-272156fdc1b7 | 2024-10-17 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 6c5b5427-e47a-4eff-928a-c891452facf9 | 2024-10-17 | Warnings | M012 |
| COLD AND FLU SEVERE | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20baef9-6e68-6679-e053-2a95a90a2b63 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20b71fb-8787-c871-e053-2a95a90a8eb4 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20bc492-fed3-bf05-e053-2a95a90ad393 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | a4d6ecb9-ea67-41ed-917b-9bb4d1e50551 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 08fda81a-bedd-4ff3-9c32-2066d2cea3f9 | 2024-10-17 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | American Health Packaging | 2fd702ea-3069-472c-b99e-c527f1375705 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Selder, S.A. de C.V. | c2b49d10-b60f-3072-e053-2a95a90af004 | 2024-10-17 | Warnings | M012 |
| Head Congestion plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 1db914d3-8bba-405e-9bf9-9b1a5806284c | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | e2c35fae-9dd6-51f2-e053-2995a90a1e9e | 2024-10-17 | Warnings | M012 |
| Cough and Cold XL3 Xtra | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | da5b31dd-becd-471a-9392-d0ee4b8f9539 | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | MIDWAY IMPORTING INC. | 58252f15-485c-3061-e053-2a91aa0a2320 | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Midway Importing, Inc. | e41b9beb-e274-5c02-e053-2995a90ad0f8 | 2024-10-17 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 38e70a28-eff2-4a48-b829-8cd68e80beef | 2024-10-17 | Warnings | M012 |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Midway Importing Inc. | c2c8bd26-bbf1-c2e6-e053-2995a90a86a7 | 2024-10-17 | Warnings | M012 |
| Antiflu Des Cough and Flu | ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE | Productos Farmaceuticos, S.A. de C.V. | dcf3897a-a793-6df7-e053-2995a90a25f8 | 2024-10-17 | 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 |