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 | 2026-10-27 | ||
| excluded package | package | 0225-0610 | 0225-0610-23 | D | Discontinued by firm | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| Theraflu Severe Cold relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 0d3b1bea-e2ca-4e07-8ae5-60627d230c96 | 2024-03-08 | Warnings | M012 |
| Theraflu PowerPods Daytime Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | e655c33c-c319-41d9-ae55-cf747242cd10 | 2024-03-08 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | adf33520-4689-4de2-b9d8-c201518e9d26 | 2024-03-08 | Warnings | M012 |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7 | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 62f7fcb9-e31a-4634-b1c2-44a9567e3a61 | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Severe Cold and Flu Caplets | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 8e22f6bc-33ce-4bb0-99be-7947aa21f60e | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Severe Cold and Flu Syrup | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 777d2ac7-e3cc-4513-8b6f-b90b2ff2c672 | 2024-03-07 | Warnings | M012 |
| Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | CVS Pharmacy | 4c6025ff-4982-4408-b077-75dd5f5b65b2 | 2024-03-07 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | 423fd5e6-5d90-4539-81e0-0ae23881ee3a | 2024-03-07 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 917df706-1982-4240-9f56-42d426b76cc5 | 2024-03-06 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 21a29998-29d6-4a36-a370-291d23bfb197 | 2024-03-05 | Warnings | M012 |
| Multi-Symptom Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 3c7ef3cf-f7f9-42bc-bf20-e36954b9671f | 2024-03-05 | Warnings | M012 |
| QUALITY CHOICE NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | da06e994-6848-4c1e-9432-31de5e626ea4 | 2024-03-02 | Warnings | M012 |
| QUALITY CHOICE DayTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 417c4fa9-6458-40d0-b22a-2415194e250f | 2024-03-02 | Warnings | M012 |
| DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Aurohealth LLC | 8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2 | 2024-03-01 | Warnings | M012 |
| APRODINE | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | A-S Medication Solutions | bbc268b8-fa66-4dc5-b935-f77ae39d28c8 | 2024-02-29 | Warnings | M012 |
| XtraCare Vaporizing Chest Rub | CAMPHOR, MENTHOL | Rejoice International | c3e220d6-fff4-452f-99a9-bd701fc608a0 | 2024-02-28 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | ebbb2f4b-ba84-40ad-96f6-60225119a33b | 2024-02-27 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AMERISOURCE BERGEN | 1c93c45d-1141-4599-83ba-6d3b38f9ffc4 | 2024-02-23 | 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 |