Denorex Extra Strength
- Product NDC
- 62673-059
- Requested package NDC
- 62673-059-10
- 11-digit product format
- 626730059
- Labeler code
- 62673
- Product ID
- 62673-059_4ed2043a-0f5e-a764-e063-6394a90aa3bd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Salicylic Acid
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Labeler
- Neoteric Cosmetics, Inc.
- Application
- M032
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-06-17
- Marketing end
- 2029-02-28
- Substance
- SALICYLIC ACID
- Active strength
- .03 g/mL
- NDC exclude flag
- No
- Current FDA listing
- Yes
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | fb8cb913e6d1… | eb8c232b6be0… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Denorex Extra Strength
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SALICYLIC ACID | .03 g/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| O414PZ4LPZ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 21d234ff-f379-4bcd-9ba0-90f27c6d3a69 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62673-059-10 | 2024-12-18 | C162847 | 48780-1 | e4f33bdf-a537-d8a0-e053-dadaa90a6e4e | Denorex Extra Strength with Conditioner |
| 62673-059-10 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a537-d8a0-e053-dadaa90a6e4e | Denorex Extra Strength with Conditioner |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62673-059-10 | Denorex Extra Strength | 296 mL in 1 BOTTLE | SHAMPOO | 296 | 4 |
DailyMed Dashboard NDC Coverage#
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 and Shoulders Smooth and Silky Kit | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4d38902f-a6ae-620f-e063-6394a90ae932 | 2026-03-17 | Warnings | M032 |
| RoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo. | SALICYLIC ACID 3% | RoyceDerm LLC | 4d2f6e29-5d75-6982-e063-6294a90ada8d | 2026-03-16 | Warnings | M032 |
| Dry Scalp Care | PYRITHIONE ZINC | CVS Pharmacy, Inc. | f286a5fd-7916-49bc-97a1-ad737ac5b14a | 2026-03-13 | Warnings, Adverse reactions | M032 |
| Head and Shoulders Itchy Scalp | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 54df1acc-4265-494c-879e-c690184d7ae2 | 2026-03-13 | Warnings | M032 |
| 2 in 1 Dandruff | PYRITHIONE ZINC | H E B | a58b9119-2adb-459f-86f4-95df28a430c5 | 2026-03-13 | Warnings, Adverse reactions | M032 |
| Dry Scalp Care | PYRITHIONE ZINC | Better Living Brands, LLC | f90d1fb2-4bd7-4d70-81b4-4541f4e3a3d6 | 2026-03-13 | Warnings, Adverse reactions | M032 |
| Head and Shoulders Smooth and Silky Conditioner | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 4cec08cb-aba5-41ce-e063-6294a90adfdf | 2026-03-13 | Warnings | M032 |
| OLIVITA Minoxidil | MINOXIDIL | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 4cf37b0b-bbb8-1d9c-e063-6294a90af818 | 2026-03-13 | Warnings | M032 |
| Dandruff | PYRITHIONE ZINC | Nice-Pak Products, LLC | 3c55b70f-7627-8667-e063-6394a90a5cf8 | 2026-03-12 | Warnings, Adverse reactions | M032 |
| Head and Shoulders 2in1 Classic Clean | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | 65a4082f-227b-49bf-b88c-b1c651ed13a0 | 2026-03-12 | Warnings | M032 |
| Head and Shoulders Green Apple 2in1 | PYRITHIONE ZINC | The Procter & Gamble Manufacturing Company | c036c9a6-6507-4037-b97b-1b015dd950c1 | 2026-03-12 | Warnings | M032 |
| Anti-Fungal | ANTI-FUNGAL SHAMPOO | Shenzhen Mengyue Technology Co., Ltd. | 4ca9a661-fa39-ab7f-e063-6294a90aed14 | 2026-03-10 | Warnings | M032 |
| iBeaLee 5% Minoxidil Hair Regrowth Treatment | 5% MINOXIDIL | Shenzhen Earth Surface Trading Co., Ltd. | 4cb728d0-6abe-6645-e063-6394a90acb4c | 2026-03-10 | Warnings | M032 |
| DHS Tar | COAL TAR | Person and Covey | 4c5f7278-c53a-cef6-e063-6394a90a0008 | 2026-03-09 | Warnings | M032 |
| DHS ZINC | PYRITHIONE ZINC | Person and Covey | 4c98c0af-c3d0-211e-e063-6294a90a8e12 | 2026-03-09 | Warnings | M032 |
| DHS SAL | SALICYLIC ACID | Person and Covey | 4c9b75b5-9c7d-c4a8-e063-6394a90a4a6b | 2026-03-09 | Warnings | M032 |
| DHS BODY WASH | ZINC PYRITHIONE WASH | Person and Covey | 4c9d5b33-9a1e-9db1-e063-6294a90adbae | 2026-03-09 | Warnings | M032 |
| Biotin | BIOTIN | Shenzhen yuehaotong Technology Co.,Ltd | 4c6ec616-a84e-6e1a-e063-6294a90a2aae | 2026-03-07 | Warnings | M032 |
| 2 in 1 Dandruff | PYRITHIONE ZINC | Old East Main Co. | 5368b466-a804-471c-8287-0dd120c0d509 | 2026-03-03 | Warnings, Adverse reactions | M032 |
| Dandruff | PYRITHIONE ZINC | Amazon.com Services LLC | c187bb79-8190-4a3d-a966-af74198ee546 | 2026-03-03 | Warnings, Adverse reactions | M032 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1303358 | Denorex Extra Strength 3 % Medicated Shampoo, Reformulated Aug 2012 | PSN | 21d234ff-f379-4bcd-9ba0-90f27c6d3a69 | 4 |
| 205023 | salicylic acid 3 % Medicated Shampoo | PSN | 21d234ff-f379-4bcd-9ba0-90f27c6d3a69 | 4 |
| 1303358 | salicylic acid 30 MG/ML Medicated Shampoo [Denorex Extra Strength Reformulated Aug 2012] | SBD | 21d234ff-f379-4bcd-9ba0-90f27c6d3a69 | 4 |
| 205023 | salicylic acid 30 MG/ML Medicated Shampoo | SCD | 21d234ff-f379-4bcd-9ba0-90f27c6d3a69 | 4 |
| 1303358 | Denorex Extra Strength 3 % Medicated Shampoo, Reformulated Aug 2012 | SY | 21d234ff-f379-4bcd-9ba0-90f27c6d3a69 | 4 |
| 1303358 | Denorex Extra Strength Reformulated Aug 2012 30 MG/ML Medicated Shampoo | SY | 21d234ff-f379-4bcd-9ba0-90f27c6d3a69 | 4 |
| 205023 | salicylic acid 3 % Medicated Shampoo | SY | 21d234ff-f379-4bcd-9ba0-90f27c6d3a69 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62673-059-10 | 62673005910 | 296 mL in 1 BOTTLE (62673-059-10) | 296 ml | 2019-06-17 | 2029-02-28 | No | No | Current |