Head and Shoulders
- Product NDC
- 37000-078
- 11-digit product format
- 370000078
- Labeler code
- 37000
- Product ID
- 37000-078_4cda90a8-cfc7-00fd-e063-6294a90aa27d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pyrithione Zinc
- Dosage form
- LOTION/SHAMPOO
- Route
- TOPICAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M032
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-09-01
- Substance
- PYRITHIONE ZINC
- Active strength
- 1 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 37000-078 | 37000-078-01 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 37000-078 | 37000-078-11 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 37000-078 | 37000-078-12 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 37000-078 | 37000-078-25 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 37000-078 | 37000-078-40 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 37000-078 | 37000-078-70 | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-95 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-11 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-25 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-70 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-95 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-11 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-25 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-70 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-95 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-11 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-25 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-70 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-95 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-11 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-25 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-70 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-95 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-11 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-25 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-70 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-40 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-95 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-11 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-25 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-70 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-40 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-95 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-11 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-25 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-12 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-70 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-40 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-95 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-11 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-25 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-12 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-70 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 37000-078-40 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 37000-078-95 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 37000-078-11 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 37000-078-25 | 0efc9e666f02… | f202fb6c5f17… |
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
- Head and Shoulders
- Brand name suffix
- Green Apple 2in1
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PYRITHIONE ZINC | 1 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R953O2RHZ5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c036c9a6-6507-4037-b97b-1b015dd950c1 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37000-078-01 | Head and ShouldersGreen Apple 2in1 | 1000 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 1000 | 13 | |
| 37000-078-02 | Head and ShouldersGreen Apple 2in1 | 950 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 950 | 13 | |
| 37000-078-02 | Head and ShouldersGreen Apple 2in1 | 2 in 1 CELLO PACK | LOTION/SHAMPOO | 2 | 13 | |
| 37000-078-11 | Head and ShouldersGreen Apple 2in1 | 1180 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 1180 | 13 | |
| 37000-078-12 | Head and ShouldersGreen Apple 2in1 | 1280 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 1280 | 13 | |
| 37000-078-25 | Head and ShouldersGreen Apple 2in1 | 250 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 250 | 13 | |
| 37000-078-37 | Head and ShouldersGreen Apple 2in1 | 370 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 370 | 13 | |
| 37000-078-40 | Head and ShouldersGreen Apple 2in1 | 400 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 400 | 13 | |
| 37000-078-61 | Head and ShouldersGreen Apple 2in1 | 613 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 613 | 13 | |
| 37000-078-70 | Head and ShouldersGreen Apple 2in1 | 700 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 700 | 13 | |
| 37000-078-83 | Head and ShouldersGreen Apple 2in1 | 835 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 835 | 13 | |
| 37000-078-95 | Head and ShouldersGreen Apple 2in1 | 950 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 950 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 37000-078 | HEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 12 | Current NDC, Legacy NDC, 12 package rows | 20241020_c036c9a6-6507-4037-b97b-1b015dd950c1.zip |
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 |
|---|---|---|---|---|---|---|
| Dove Men Care | ANTI-DANDRUFF 2IN1 SHAMPOO AND CONDITIONER | Conopco d/b/a Unilever | 4ecce67b-b2e0-b757-e063-6294a90a224e | 2026-04-07 | Warnings | M032 |
| Dove Men Care | ANTI-DANDRUFF DRYNESS AND ITCH RELIEF 2 IN 1 SHAMPOO AND CONDITONER | Conopco d/b/a Unilever | 4edfa86c-0139-5bc5-e063-6294a90a5d73 | 2026-04-07 | Warnings | M032 |
| Dove | SOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF SHAMPOO | Conopco d/b/a Unilever | 4ecb2eac-0d1c-b59d-e063-6394a90a49e3 | 2026-04-06 | Warnings | M032 |
| Happy Head Anti-Dandruff | PYRITHIONE ZINC | Happy Head, Inc | f0d5daea-72fc-4e40-a390-9da42cadbe3a | 2026-04-06 | Warnings | M032 |
| Dove | CALMING RELIEF DAMAGE THERAPY ANTI-DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONER | Conopco d/b/a Unilever | 4ecc1232-065f-c63e-e063-6394a90ac63b | 2026-04-06 | Warnings | M032 |
| Suave Professionals Men 2 in 1 Classic Clean AntiDandruff | PYRITHIONE ZINC | Conopco Inc. d/b/a Unilever | d85e52e5-c3e2-4be0-aa3f-3511a69ecc4f | 2026-04-03 | Warnings | M032 |
| Denorex Multi-Symptom Anti-Dandruff | SALICYLIC ACID | Neoteric Cosmetics, Inc. | 4e904a6b-a732-558b-e063-6294a90ac642 | 2026-04-01 | Warnings | M032 |
| Denorex Extra Strength | SALICYLIC ACID | Neoteric Cosmetics, Inc. | 21d234ff-f379-4bcd-9ba0-90f27c6d3a69 | 2026-04-01 | Warnings | M032 |
| EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00 | EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00 | Qingyuan Moksha Biotechnology Co., Ltd. | 4e386cc8-004a-9742-e063-6394a90a763c | 2026-03-30 | Warnings | M032 |
| Tio Nacho Anti-Dandruff | SALICYLIC ACID | Genomma Lab USA | c3c92b35-4955-4985-9a1d-8756c1b2131c | 2026-03-27 | Warnings | M032 |
| Suave Antidandruff 2 IN 1 Classic Clean | ANTI DANDRUFF 2N1 SHAMPOO AND CONDITIONER | Suave Brands Co., LLC | 41d9cfec-6d14-f620-e063-6294a90a078d | 2026-03-26 | Warnings | M032 |
| Suave Anti dandruff Coconut Moisture | ANTI DANDRUFF SHAMPOO | Suave Brands Co., LLC | 41da3d90-4845-0d8f-e063-6294a90aede1 | 2026-03-26 | Warnings | M032 |
| Suave Men 2 IN1 Scalp Defense | ANTI DANDRUFF SHAMPOO AND CONDITIONER | Suave Brands Co., LLC | 42517082-4d0a-90a3-e063-6294a90a5927 | 2026-03-26 | Warnings | M032 |
| Suave Men Antidandruff 2 IN 1 Classic Clean | ANTI DANDRUFF SHAMPOO AND CONDITIONER | Suave Brands Co., LLC | 425264b9-62a9-fd7b-e063-6294a90a37a2 | 2026-03-26 | Warnings | M032 |
| Pyrithione Zinc | PYRITHIONE ZINC | Nice-Pak Products, LLC | 4db2aaf4-5caf-d9e5-e063-6294a90aa4ea | 2026-03-23 | Warnings, Adverse reactions | M032 |
| MG217 Psoriasis Medicated multi-symptom | COAL TAR | Wisconsin Pharmacal Company | 7cb04d20-9b3c-27bb-e053-2a91aa0a5bc4 | 2026-03-20 | Warnings | M032 |
| MG217 Psoriasis Therapeutic Conditioner | SALICYLIC ACID | Wisconsin Pharmacal Company | 246f239f-16fb-24b2-e054-00144ff8d46c | 2026-03-20 | Warnings | M032 |
| Dermeleve Scalp Psoriasis Treatment | SALICYLIC ACID | Advanced Derm Solutions LLC | f55da7a8-0a26-4925-bd3b-fade6156116d | 2026-03-19 | Warnings | M032 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043244 | head & shoulders 1 % Medicated Shampoo | PSN | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 209884 | zinc pyrithione 1 % Medicated Shampoo | PSN | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 1043244 | zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders] | SBD | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 209884 | zinc pyrithione 10 MG/ML Medicated Shampoo | SCD | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 1043244 | Head & Shoulders 1 % Medicated Shampoo | SY | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 1043244 | Head & Shoulders 10 MG/ML Medicated Shampoo | SY | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 209884 | zinc pyrithione 1 % Medicated Conditioner | SY | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 209884 | zinc pyrithione 1 % Medicated Shampoo | SY | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-078-01 | 37000007801 | 1000 mL in 1 BOTTLE, PUMP | 1000 ml | Historical | ||||
| 37000-078-02 | 37000007802 | 2 BOTTLE, PUMP in 1 CELLO PACK (37000-078-02) / 950 mL in 1 BOTTLE, PUMP | 2021-01-01 | 0000-00-00 | No | No | Current | |
| 37000-078-11 | 37000007811 | 1180 mL in 1 BOTTLE, PUMP | 1180 ml | Historical | ||||
| 37000-078-12 | 37000007812 | 1280 mL in 1 BOTTLE, PUMP (37000-078-12) | 1280 ml | 2017-01-17 | 0000-00-00 | No | No | Current |
| 37000-078-25 | 37000007825 | 250 mL in 1 BOTTLE, PLASTIC | 250 ml | Historical | ||||
| 37000-078-37 | 37000007837 | 370 mL in 1 BOTTLE, PLASTIC (37000-078-37) | 370 ml | 2022-12-01 | No | No | Current | |
| 37000-078-40 | 37000007840 | 400 mL in 1 BOTTLE, PLASTIC (37000-078-40) | 400 ml | 2013-09-13 | 0000-00-00 | No | No | Current |
| 37000-078-61 | 37000007861 | 613 mL in 1 BOTTLE, PLASTIC (37000-078-61) | 613 ml | 2022-12-01 | No | No | Current | |
| 37000-078-70 | 37000007870 | 700 mL in 1 BOTTLE, PLASTIC (37000-078-70) | 700 ml | 2013-09-13 | 0000-00-00 | No | No | Current |
| 37000-078-83 | 37000007883 | 835 mL in 1 BOTTLE, PUMP (37000-078-83) | 835 ml | 2022-12-01 | No | No | Current | |
| 37000-078-95 | 37000007895 | 950 mL in 1 BOTTLE, PUMP (37000-078-95) | 950 ml | 2016-10-01 | 0000-00-00 | No | No | Current |